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

Catalog Number 42065100-080

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 is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was to treat the popliteal femoral artery.The vessel diameter was 6.5mm and pre-dilatation was performed with a balloon inflated once to 5 atmospheres (atms).The 6.5x100mm supera self-expanding stent system (sess) stent could not be fully detached from the delivery system.There were no issues with the deployment mechanism and stent was partially deployed but could not detach from the sess after pushing the second (final) deployment lock.The stent and sess were removed together.There was no adverse patient effect and there was no reported clinically significant delay in the procedure.No additional information was provided.

Event Description

It was reported that the procedure was to treat an unspecified artery.The 6.5x100mm supera self-expanding stent system (sess) stent could not be fully detached from the delivery system.The stent and sess were removed together.There was no adverse patient effect and there was no reported clinically significant delay in the procedure.Subsequent to the initially filed report, the following information was provided: the procedure was to treat the popliteal femoral artery.The vessel diameter was 6.5mm.Pre-dilatation was performed with a balloon inflated once to 5 atmospheres (atms).There were no issues with the deployment mechanism and stent was partially deployed but could not detach from the sess after pushing the second (final) deployment lock.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 anatomy resulted in the ratchet being unable to properly engage and release the stent from the delivery system thus resulting in 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.D9, h3 - it was initially reported that the device would be returned for analysis.Subsequent information revealed that the device was discarded and is not available for evaluation.

• 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: 12879675
• MDR Text Key: 284381261
• Report Number: 2024168-2021-10827
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 01/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Catalogue Number: 42065100-080
• Device Lot Number: 0101461
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/09/2021
• Initial Date FDA Received: 11/26/2021
• Supplement Dates Manufacturer Received: 12/29/2021
• Supplement Dates FDA Received: 01/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2020
• 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