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

Model Number S-65-150-120-P6

Device Problems Difficult to Remove (1528); Stretched (1601)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/20/2022

Event Type  Injury  

Event Description

It was reported that the procedure was to treat a right distal superior femoral artery (sfa).The 6.5x150mm supera self-expanding stent was deployed; however, during removal under fluoroscopy the tip of supera delivery system became caught on the deployed stent.This caused stent elongation to 200 length instead of the original 150 length.The physician unlocked system and tried to slide the thumbslide to see if nosecone would move forward to disengage the stent.He advanced the entire delivery system forward and was able to get it to disengage.Additional balloon dilatation was performed with an 6.0mm armada 35 balloon dilatation catheter to improve the stent lumen.Some of the stent is in healthy tissue.The profunda was almost covered by the stent that was meant to treat the distal sfa in the right leg.There were no adverse patient sequela reported and no clinically significant delay reported.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that during removal the tip of supera delivery system inadvertently became caught on the deployed stent resulting in the reported difficult to remove and the reported stretched stent.Some of the stent was deployed in healthy tissue resulting in the foreign body in patient.The treatment (manipulation to disengage the tip) 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.

• 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: 15780600
• MDR Text Key: 303565764
• Report Number: 2024168-2022-11495
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08717648226328
• UDI-Public: 08717648226328
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: S-65-150-120-P6
• Device Catalogue Number: S-65-150-120-P6
• Device Lot Number: 1092761
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2021
• 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: 6.0 ARMADA 35
• Patient Sex: Male