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

Model Number S-55-060-120-P6

Device Problems Difficult to Remove (1528); Material Separation (1562); Activation Failure (3270)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/16/2021

Event Type  Injury  

Manufacturer Narrative

The stent remains in the patient.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported this was a procedure to treat a heavily calcified superficial femoral artery.A supera stent was inserted and advanced to the target lesion.However, during deployment, the stent was unable to be release.The physician attempted to remove the stent, but when the stent reached the anterior tibial branch, it detached from the delivery system.It was noted that resistance was felt when the stent was pulled into the tibial.No treatment was performed in an attempt to remove the stent.An additional supera stent was then inserted and advanced to the original target lesion and was successfully deployed without issues.There was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device was not returned for evaluation.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 revealed no other incidents and/or complaints reported from this lot.Based on the information provided, a definitive cause for the reported difficulties could not be determined.It may be possible that the distal sheath of the supera delivery system was entrapped or restricted within in the anatomy such that the ratchet ears were unable to properly engage the stent preventing full deployment; however, this could not be confirmed.Reportedly, the stent released from the delivery system during withdrawal of the delivery system causing resistance and the stent to release when it reached the anterior tibial branch.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• 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
• MDR Report Key: 11806710
• MDR Text Key: 250075098
• Report Number: 2024168-2021-03981
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08717648226083
• UDI-Public: 08717648226083
• Combination Product (y/n): N
• PMA/PMN Number: P120020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Model Number: S-55-060-120-P6
• Device Catalogue Number: S-55-060-120-P6
• Device Lot Number: 9081461
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 72 YR