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

Catalog Number 42060150-120

Device Problem Material Separation (1562)

Patient Problems Pain (1994); Thrombosis/Thrombus (4440)

Event Date 06/28/2023

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2023 a 6.0x150mm supera stent was implanted over the knee in the popliteal artery without issue and good result.On (b)(6) 2023 the patient returned experiencing leg pain.Angiography was performed and thrombus was noted in the implanted stent.Thrombolysis was started on the patient.On (b)(6) 2023 the patient returned to operating room and it was confirmed that the thrombolysis was as successful with no thrombus remaining; however, the previously implanted stent was noted to have become separated into two pieces.Pre-dilatation was performed and a 6.0x100mm supera stent was implanted to cover the separated portion of the stent with a good result and good flow.There was no adverse patient sequela.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.A cine was received and reviewed by an abbott vascular clinical specialist.While reviewing the media, the initial supera stent on the radiograph appears to have clinically acceptable expansion/deployment with the separation occurring mid-way through the stent.It also cannot be determined when this separation occurred, whether it was during initial deployment, or during the thrombolysis procedure.After reviewing the information and the media in the report, a probable cause for the event cannot be determined.In this case, the investigation determined a conclusive cause for the reported difficulties cannot be determined.Additionally, the reported difficulties possibly caused/contributed to the reported patient effects, however a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.The reported patient effects of stent thrombosis and pain are listed in the supera peripherial stent system instructions for use as potential adverse effects of peripheral percutaneous intervention.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.

Event Description

The following additional information received: when the patient returned on 6/28/2023, the angiography performed prior to the thrombolysis procedure showed the stent was fractured.The thrombolysis catheter was unable to be advanced through the stent due to the separation.A small balloon was used to open the path which then allowed the thrombolysis catheter to be advanced.No additional information was provided.

Manufacturer Narrative

Revised: the separation located mid-way through the stent occurred prior to the thrombolysis as viewed on the media; however, it cannot be determined when this separation occurred.After reviewing the information and the media in the report, a probable cause for the stent fracture could not be determined.In this case, the investigation determined a conclusive cause for the reported difficulties cannot be determined.The reported stent fracture possibly caused/contributed to the reported patient effects, however a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.The treatment(s) 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.H6: investigation findings 213, investigation conclusions 67, 22 were removed.

• 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: 17383291
• MDR Text Key: 319620571
• Report Number: 2024168-2023-07911
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 08/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2023
• 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: 42060150-120
• Device Lot Number: 2020361
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2022
• 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; Hospitalization