ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM
Report
- Report Number
- 2024168-2020-01828
- Event Type
- Injury
- 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. (B)(4).
LITERATURE ATTACHMENT (CN-23446): "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 ARTICLE COMPARED ONE-YEAR OUTCOMES OF BRAIDED SELF-EXPANDING STENTS MADE OF NITINOL TO OTHER CONTEMPORARY BARE NITINOL STENTS (BNS). ABSOLUTE PRO VASCULAR SELF-EXPANDED STENT SYSTEM (SESS) MADE UP 14.2% OF THE BARE NITINOL STENT (BNS) GROUP, WHICH INCLUDED DEVICES MANUFACTURED BY MULTIPLE MANUFACTURERS. ALTHOUGH ONE-YEAR RESULTS FOR TARGET LESION RESTENOSIS AND TARGET VESSEL REVASCULARIZATION ARE PRESENTED FOR THE BNS GROUP, THE RELATIONSHIP OF THE ABSOLUTE PRO VASCULAR DEVICE TO THE PATIENT EFFECTS CANNOT BE ESTABLISHED AS THE ARTICLE DOES NOT LIST THE OUTCOMES IN RELATION TO THE STENT NAME.
ESTIMATED DATES: DATE OF EVENT AND 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 RESTENOSIS IS LISTED IN THE ABSOLUTE PRO INSTRUCTIONS 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. THE ADDITIONAL ADVERSE PATIENT EFFECT OF DEATH AND DEVICE MALFUNCTIONS REFERENCED ARE BEING FILED UNDER SEPARATE MEDWATCH REPORT #S. THE VISION AND SUPERA STENTS REFERENCED ARE BEING FILED UNDER SEPARATE MEDWATCH REPORT #S.
IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING SUPERA, ABSOLUTE, 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".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 226668 | ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM | SELF EXPANDING PERIPHERAL STENT SYSTEM | FGE | ABBOTT VASCULAR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Hospitalization| R |