Total Adverse Events: 162
Mechanical only: 65%
Source:
-U.S. Food and Drug Administration
https://www.fda.gov/medical-devices/med ... pt.com#asr
-AI tools for parsing stats from Event Text (AI can make mistakes)
-MAUDE Reports are often incomplete, inaccurate, or unverified, making it harder to establish definitive causality or calculate the true incidence of adverse events.
AMS 700 Time To Failure (TTF) Statistics (in Years) for limited 100 failed samples with reported Date of Manufacture and Event Date
Code: Select all
Failure Type | Mean | Median | Min | Max
-------------------------------------------
Mechanical | 4.1 | 2.8 | 0.1 | 13.4
Biological | 1.5 | 0.7 | 0.2 | 9.8
1. Timing: "Early Rejection vs. Late Wear-Out"
The most striking insight from the data is the distinct temporal difference between Biological and Mechanical failures.
Biological Failures = Acute/Early Issues:
- According to the summary table and box plots, Biological failures occur much earlier. The Median Time to Failure (TTF) is only 0.7 years (approx. 8.5 months).
- Looking at the "Subtype TTF" chart, Wound/Tissue Issues and Infections are clustered heavily near the zero mark. This suggests that if a biological failure is going to happen, it is usually a post-operative complication or rejection occurring within the first year.
- Exception: "Erosion/Extrusion" has a wider spread, indicating that while infection is immediate, the body can slowly reject the device over several years.
Mechanical Failures = Chronic/Endurance Issues:
- Mechanical failures are issues of longevity. The Median TTF is 2.8 years, with a Mean of 4.1 years.
- The box plots show a much wider spread for mechanical issues. Cylinder and Pump failures frequently reach into the 8–10+ year range. This indicates these components are generally durable but subject to wear-and-tear over time.
2. Frequency: Mechanical Issues Dominate
The "Verified Failure Percentages" bar chart provides context on risk probability.
- Tubing is the Weakest Link: The single most common failure mode is Tubing (34.6%). This is a mechanical failure. Combined with Pumps (20.1%) and Cylinders (7.5%), the vast majority of revisions or failures are caused by the device breaking, not the body rejecting it.
- Infection is the Primary Biological Risk: At 9.4%, infection is the most significant biological risk, but it still occurs less frequently than pump or tubing malfunctions.
3. Deep Dive into Subtypes (The Box Plot)
The "Time To Failure: Mechanical vs Biological" box plot offers granular detail:
- Immediate Threats (<1 Year): Wound issues and Infections have very tight interquartile ranges (the colored boxes) close to the bottom. These are the immediate hurdles.
- Mid-Term Threats (1–4 Years): Hernia/Migration and General Mechanical Malfunctions tend to appear in this window.
- Long-Term Threats (4+ Years): The Pump, Reservoir, and Cylinders have the tallest "whiskers" and highest medians. If the device survives the initial biological acceptance phase, these mechanical components are what will eventually limit the lifespan of the device.
Summary Conclusion
The data paints a picture of two distinct risk periods for the patient:
- The First Year (The Biological Hurdle): The primary risks are Infection and Wound issues. If the patient passes the 1-year mark without these issues, the likelihood of a biological failure drops significantly.
- Years 2–10+ (The Mechanical Limit): Once the body accepts the device, the clock starts ticking on mechanical endurance, with Tubing being the component most likely to fail, followed by the Pump.
