MAUDE Adverse Event Report: ABBOTT VASCULAR UNKNOWN SUPERA; SELF EXPANDING PERIPHERAL STENT SYSTEM

Catalog Number UNK SUPERA

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Sepsis (2067)

Event Date 01/01/2019

Event Type  Death  

Manufacturer Narrative

The date of event has been estimated.The date of implant has been estimated.The device was not returned for analysis.The lot history record for this product could not be reviewed because the product was not returned for evaluation and the part and lot numbers were not reported.Based on the case information, a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.The reported patient effect of death is listed in the supera instructions for use as a known potential adverse effect of peripheral percutaneous intervention.There is no indication of a product quality issue with respect to manufacture, design or labeling.The udi number is unknown as the part and lot #s were not provided.The additional patient effects referenced are being reported on a separate medwatch report #.

Event Description

It was reported through a research article identifying supera that may be related to the target lesion restenosis, major amputation, re-intervention, sepsis and death.Specific patient information is documented as unknown.Details are listed in the attached article, titled interwoven nitinol stents versus drug eluting stents in the femoro-popliteal segment: a propensity matched analysis.

Manufacturer Narrative

The reported patient effect of sepsis is listed in the supera instructions for use as a known potential adverse effect of peripheral percutaneous intervention.Based on the case information, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.H10: added patient code 2067, sepsis.Sepsis was a cause of death.

• Brand Name: UNKNOWN SUPERA
• Type of Device: SELF EXPANDING PERIPHERAL STENT SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10308837
• MDR Text Key: 199888345
• Report Number: 2024168-2020-06108
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• PMA/PMN Number: P120020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup
• Report Date: 07/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK SUPERA
• Device Lot Number: UNKNOWN SUPERA
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 73 YR