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

Catalog Number 42055150-120

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/10/2022

Event Type  Injury  

Manufacturer Narrative

The device will be returned for analysis.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was to treat a right superficial femoral artery.A 5.5x150mm supera device was advanced to the lesion and deployed without issue.The delivery system was removed outside of the patient when it was noted that the white taper tip was not present on the device as it was removed off the guide wire.Fluoroscopy demonstrated that the tip was still on the guide wire, but at the end of the 6fr sheath.A snare device was used to successfully remove the broken tip.A clinically significant delay was reported as intervention was performed to remove the broken tip.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 interaction with the 6fr sheath resulted in the reported tip separation.The treatment(s) appears to be related to the operational context of the procedure as a snare device was used to successfully remove the broken tip.A clinically significant delay was reported as intervention was performed to remove the broken tip.There is no indication of a product quality issue with respect to manufacture, design or labeling.D9, h3: device status changed from yes to no.

• 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: 14863490
• MDR Text Key: 295021081
• Report Number: 2024168-2022-07061
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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,Followup
• Report Date: 07/27/2022

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Catalogue Number: 42055150-120
• Device Lot Number: 2020161
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/12/2022
• Initial Date FDA Received: 06/29/2022
• Supplement Dates Manufacturer Received: 07/22/2022
• Supplement Dates FDA Received: 07/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2022
• 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
• Patient Outcome(s): Required Intervention