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

Catalog Number 42045020-120

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

Patient Problems Pain (1994); Stenosis (2263); Obstruction/Occlusion (2422)

Event Date 05/10/2022

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation.A review of the lot history record of the reported lot could not be conducted because the lot number was not provided.The reported patient effects of stenosis, occlusion and pain are listed in the supera peripheral stent systems instructions for use as potential adverse effects.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.However, 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.B3: date of event estimated as 05/10/2022.

Event Description

It was reported the 4.50x120mm supera stent was implanted in the popliteal bypass on (b)(6) 2021.Six months post procedure, the patient presented with pain in the leg and in-stent stenosis was noted, which was treated with a drug coated balloon.A few months later, the supera stent was occluded.The physician decided to not treat the occlusion as the patient has many collaterals that allow blood flow.No additional information was provided.

• Brand Name: SUPERA SELF-EXPANDING 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: 18977764
• MDR Text Key: 338586342
• Report Number: 2024168-2024-03648
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: P120020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 42045020-120
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/06/2024
• Initial Date FDA Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: No
• 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