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

Catalog Number 42045040-120

Device Problems Material Separation (1562); Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/26/2024

Event Type  malfunction  

Event Description

It was reported that the procedure was to treat the popliteal and distal part of the left superficial femoral artery.After the 4.5x40 mm supera self expanding stent (ses) was released in the target lesion, the distal end of the delivery system detached and was found in the artery.The delivery system was not removed under fluoroscopy and the thumb slide was not fully retracted to the start position and both the system with deployment levers locked prior to removal.A lasso was used to retrieve the detached piece with difficulty.The procedure duration was increased; however, there was no impact to the patient.Subsequent to filing an initial report for cn-213463, an additional supera tip was received detached from the rest of the device.The newly received separated tip is being filed under this report.No additional information was provided.

Manufacturer Narrative

The additional supera device mentioned in b5 is filed under a separate medwatch number.The device was returned for analysis.A visual inspection was performed on the returned device (tip and tip lumen).Electronic lot history record (elhr) and exception reviews were performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed there is no indication of a lot level product quality issue.As there is no specific information on this complaint, the investigation was unable to determine a conclusive cause for the reported/noted difficulties.Based on the reported information and results of the complaint investigation there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• 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: 19075443
• MDR Text Key: 340102538
• Report Number: 2024168-2024-04477
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08717648224867
• UDI-Public: (01)08717648224867(17)240930(10)2102161
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 04/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 42045040-120
• Device Lot Number: 2102161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/21/2022
• 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
• Treatment: 6F TERUMO INTRODUCER