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

Model Number S-45-120-120-P6

Device Problem Activation Failure (3270)

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

Event Date 11/08/2021

Event Type  malfunction  

Manufacturer Narrative

The device will not be returned for evaluation, the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was to treat a 90% stenosed, moderately calcified and moderately tortuous vessel in the superficial femoral artery (sfa).The vessel diameter was 4.5mm and atherectomy was not used in the procedure.Pre-dilatation was performed using a 5mmx120mm balloon with a pressure of 8 atmospheres (atms) for 5min.The 4.5x120mm supera self-expanding stent system (sess) was attempted to be released but could not be separated from the delivery sheath.The stent and the delivery sheath were withdrawn together from the anatomy under fluoroscopy.Another supera sess was used to complete the procedure.There was no adverse patient effect and there was no reported clinically significant delay in the procedure.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.It is possible that interaction with the 90% stenosed, moderately calcified and moderately tortuous anatomy resulted in the ratchet being unable to properly engage and release the stent from the delivery system thus resulting in the reported activation failure/ deployment failure; however this cannot be confirmed.The investigation determined a conclusive cause for the reported difficulties cannot be determined.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: 12878257
• MDR Text Key: 281327476
• Report Number: 2024168-2021-10820
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08717648226007
• UDI-Public: 08717648226007
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P120020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Model Number: S-45-120-120-P6
• Device Catalogue Number: S-45-120-120-P6
• Device Lot Number: 0120761
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2020
• 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