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

Catalog Number UNK SUPERA

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

Patient Problems Myocardial Infarction (1969); Renal Failure (2041); Perforation of Vessels (2135); Stenosis (2263); Obstruction/Occlusion (2422); Respiratory Failure (2484); Vascular Dissection (3160); Embolism/Embolus (4438); Thrombosis/Thrombus (4440); Unspecified Tissue Injury (4559)

Event Date 12/01/2020

Event Type  Injury  

Manufacturer Narrative

B3: date of procedure is estimated d4: the udi is unknown due to the part/lot number was not provided.D6: date of implant is estimated the device was not returned for evaluation.A review of the lot history record of the reported lot could not be conducted because the part and lot number was not provided.The reported patient effects of embolization, myocardial infarction, renal failure, restenosis, thrombosis, occlusion, vessel dissection, vessel perforation and surgical intervention are listed in the supera peripheral stent system instructions for use as potential adverse events.A conclusive cause for the reported respiratory failure, renal failure, stenosis, embolism / embolus, vascular dissection, perforation of vessels, obstruction/ occlusion, thrombosis/ thrombus, myocardial infarction, unspecified tissue injury and the relationship to the product, if any, cannot be determined.The treatments appears to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.The additional patient effect of death referenced in b5 is captured under separate medwatch report.As multiple devices were captured in the pmcf report, additional reports were filed under manufacturing reference numbers (b)(4).Pmcf attachment rpt2131801 rev c titled: post-market clinical follow-up evaluation report peripheral self-expanding stentsna.

Event Description

It was reported through the pmcf report, that the supera stent may be related to the adverse patient effects of death, myocardial infarction, pulmonary complications, renal complications, access site complications, thrombosis, embolization, dissection, perforation, occlusion, re-stenosis, revascularization, unplanned amputation / surgical intervention and re-hospitalization.Details are listed in the attached report, titled post-market clinical follow-up evaluation report peripheral self-expanding stents please see the attached post market clinical follow up evaluation report for specific information.

• Brand Name: SUPERA PERIPHERAL STENT SYSTEM
• Type of Device: SELF EXPANDING PERIPHERAL STENT SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 16812305
• MDR Text Key: 313987903
• Report Number: 2024168-2023-04322
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P120020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK SUPERA
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization; Disability
• Patient Age: 71 YR
• Patient Sex: Male