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

Catalog Number 42055040-120

Device Problems Difficult to Remove (1528); Stretched (1601); Difficult or Delayed Activation (2577)

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

Event Date 09/07/2023

Event Type  malfunction  

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 withdrawal the delivery system inadvertently got caught on the proximal end of the stent resulting in the reported difficult to remove.Manipulation of the device ultimately resulted in the reported stretched stent.Reportedly, the delivery system was able to unhook itself and be able to removed.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

It was reported after following deployment of a 5.5.X40mm supera self-expanding stent system (sess) the proximal end of stent became caught on the delivery system during removal of the delivery system.Therefore, the stent elongated in length; however, the delivery system was able to unhook itself and be able to removed.The stent remained implanted.There was no adverse patient effects reported and no clinically significant delay reported.No additional information was provided.

Event Description

Subsequently, after the final was filed additional information was provided that when deploying the supera stent it was partially released; however, when moving the thumbsilde back and forth the stent was able to be deployed.It was also noted the stent became stretched during deployment.There was no resistance noted during removal.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 the distal sheath of the delivery system was entrapped or bent in the anatomy such that the ratchet was unable to properly/fully engage the stent resulting in the reported deployment difficulties; additionally, it is possible that further interaction/manipulation of the device in order to deploy the stent resulted in the reported stretched stent; 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.H6: medical device problem code 1528 removed.H6: investigation findings 114 removed.H6: investigation conclusions 4311 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: 17879225
• MDR Text Key: 326017525
• Report Number: 2024168-2023-10915
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 10/30/2023

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 Catalogue Number: 42055040-120
• Device Lot Number: 3020761
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/11/2023
• Initial Date FDA Received: 10/05/2023
• Supplement Dates Manufacturer Received: 10/05/2023
• Supplement Dates FDA Received: 10/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2023
• 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