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

Catalog Number UNK SUPERA

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 03/01/2018

Event Type  Injury  

Manufacturer Narrative

Date of event - estimated.The unique device identifier (udi) is unknown because the part and lot numbers were not provided.Date of implant - estimated.Date of explant - estimated.The device was not returned for analysis.A lot history review and similar incident query could not be conducted because the part and lot numbers were not provided.Based on the case information, a conclusive cause could not be determined.The reported treatment may have been due to case circumstances; however, this cannot be confirmed.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

It was reported that the supera stent possibly malfunctioned and was explanted.No additional information provided.

• Brand Name: SUPERA SELF EXPANDING 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: 11566039
• MDR Text Key: 242161259
• Report Number: 2024168-2021-02365
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK SUPERA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2021
• 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