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

Model Number	S-60-080-120-P6
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/27/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2019 a 6x80mm supera peripheral self-expanding stent (ses) was implanted without issue to cover the fractured non-abbott stent in the right superior femoral artery (sfa).Good results were achieved.On (b)(6) 2020, the patient presented with leg pain and angiography showed that the supera stent was fractured.In the physician¿s opinion, it is possible that the cause of the supera stent fracture was due to the non-abbott fractured stent blocking the mimetic movement of the supera stent.If the lesion was treated by only the supera stent, it is possible that the fracture wouldn¿t have occurred.A non-abbott stent was implanted in the supera stent with good results.There was no adverse patient sequela and no reported clinically significant delay in the procedure or therapy.No additional information was provided.
Additional 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 similar incidents from this lot.The reported patient effect of pain is listed in the supera peripheral stent system instructions for use (ifu) as a potential adverse effect of peripheral percutaneous intervention.It is possible that due to the proximity of the stents and/or stress/fatigue/repetitive movement due to anatomical conditions and the location of the implants resulted in the reported break; however, this could not be confirmed.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 effect, and the relationship to the product, if any, cannot be determined.The treatment 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
• Common Device Name: 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: 12763591
• Report Number: 2024168-2021-10083
• Device Sequence Number: 14534568
• Product Code: NIP
• UDI-Device Identifier: 08717648211812
• UDI-Public: 08717648211812
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P120020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/05/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2020
• Device Model Number: S-60-080-120-P6
• Device Catalogue Number: S-60-080-120-P6
• Device Lot Number: 8100461
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/25/2021
• Initial Report FDA Received Date: 11/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown