ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM
Report
- Report Number
- 2024168-2020-01827
- Event Type
- Death
- Date Received
- February 27, 2020
- Date of Event
- December 1, 2016
- Report Date
- September 4, 2020
- Manufacturer
- ABBOTT VASCULAR
- Product Code
- FGE
- PMA / PMN Number
- P110028
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
Narratives
THIS REPORT IS BEING RESUBMITTED TO ENSURE THE ENCLOSED ATTACHMENT CAN BE EASILY OPENED BY THE FDA.
LITERATURE ((B)(6)): "COMPARATIVE OUTCOMES OF SUPERA INTERWOVEN NITINOL VS BARE NITINOL STENTS FOR THE TREATMENT OF FEMOROPOPLITEAL DISEASE: INSIGHTS FROM THE XLPAD REGISTRY". D1: CORRECTED TO ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM. G5: CORRECTED TO PMA P110028. H6: RESULTS CODE 114 REMOVED.
IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING SUPERA, ABSOLUTE PRO VASCULAR, AND VISION STENTS THAT MAY BE RELATED TO THE FOLLOWING: MORTALITY RATES, RESTENOSIS, TARGET VESSEL/LIMB REVASCULARIZATION, STENT FRACTURE, STENT ELONGATION, AND STENT COMPRESSION. DETAILS ARE LISTED IN THE ATTACHED ARTICLE, TITLED, "COMPARATIVE OUTCOMES OF SUPERA INTERWOVEN NITINOL VS BARE NITINOL STENTS FOR THE TREATMENT OF FEMOROPOPLITEAL DISEASE: INSIGHTS FROM THE XLPAD REGISTRY". SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, IT WAS NOTED THAT THE ONE-YEAR OUTCOMES PRESENTED IN THE STUDY INCLUDED ALL-CAUSE MORTALITY. THE STUDY COMPARED SUPERA TO OTHER CONTEMPORARY BARE NITINOL STENTS (BNS) AND THE ABSOLUTE PRO VASCULAR STENT MADE UP 14.2% OF THE BNS GROUP, WHICH INCLUDED DEVICES MANUFACTURED BY MULTIPLE MANUFACTURERS. ALTHOUGH THE ALL-CAUSE MORTALITY RATE FOR THE BNS GROUP WAS LISTED IN THE ARTICLE, THE RELATIONSHIP OF THE ABSOLUTE PRO VASCULAR DEVICE TO THE PATIENT EFFECT CANNOT BE ESTABLISHED AS THE ARTICLE DOES NOT LIST THE OUTCOMES IN RELATION TO THE STENT NAME.
ESTIMATED DATES: DATE OF DEATH), DATE OF EVENT, DATE OF IMPLANT. THE UDI # COULD NOT BE PROVIDED BECAUSE THE PART AND LOT NUMBERS WERE NOT REPORTED. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE LOT AND PART NUMBER WERE NOT PROVIDED. THE REPORTED PATIENT EFFECT OF DEATH IS LISTED IN THE ABSOLUTE PRO INSTRUCTION FOR USE AS A KNOWN POTENTIAL PATIENT EFFECT ASSOCIATED WITH THE USE OF THE DEVICE. ADDITIONALLY, A CAUSE FOR THE REPORTED PATIENT EFFECT, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. LITERATURE ATTACHMENT: "COMPARATIVE OUTCOMES OF SUPERA INTERWOVEN NITINOL VS BARE NITINOL STENTS FOR THE TREATMENT OF FEMOROPOPLITEAL DISEASE: INSIGHTS FROM THE XLPAD REGISTRY". THE ADDITIONAL ADVERSE PATIENT EFFECTS AND DEVICE MALFUNCTIONS REFERENCED ARE BEING FILED UNDER SEPARATE MEDWATCH REPORT #S. THE VISION AND SUPERA STENTS REFERENCED ARE FILED UNDER SEPARATE MEDWATCH REPORT NUMBERS.
IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING SUPERA, ABSOLUTE, AND VISION STENTS THAT MAY BE RELATED TO THE FOLLOWING: DEATH, RESTENOSIS, TARGET VESSEL/LIMB REVASCULARIZATION, STENT FRACTURE, STENT ELONGATION, AND STENT COMPRESSION. DETAILS ARE LISTED IN THE ATTACHED ARTICLE, TITLED, "COMPARATIVE OUTCOMES OF SUPERA INTERWOVEN NITINOL VS BARE NITINOL STENTS FOR THE TREATMENT OF FEMOROPOPLITEAL DISEASE: INSIGHTS FROM THE XLPAD REGISTRY".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 226666 | ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM | SELF EXPANDING PERIPHERAL STENT SYSTEM | FGE | ABBOTT VASCULAR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Death |