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

Catalog Number 42055040-080

Device Problems Difficult to Remove (1528); Difficult or Delayed Activation (2577); Malposition of Device (2616)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/12/2019

Event Type  malfunction  

Manufacturer Narrative

Exemption number e2019001.The device 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 that the procedure was performed to treat a lesion in the mildly calcified, mildly tortuous, 70% stenosed popliteal artery.A 5.5x40mm supera self-expanding stent was thought to be fully deployed, but the stent was partially deployed.The tip became stuck with the stent, and the stent could not be released.After manipulation, the stent jumped, then released and was implanted.There were no adverse patient effects and no 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 revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history of the reported lot revealed no other similar incidents.The investigation determined that the reported difficulties were due to case circumstances.It is likely that the distal sheath of the delivery system was entrapped or bent in the anatomy such that the ratchet was unable to properly engage the stent resulting in partial deployment.The difficulty removing and malposition of the stent was the result of pulling back the delivery system with the stent partially deployed.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: SUPERA PERIPHERAL 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: 9581085
• MDR Text Key: 177805211
• Report Number: 2024168-2020-00594
• Device Sequence Number: 1
• Product Code: NIP
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 01/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2020
• Device Catalogue Number: 42055040-080
• Device Lot Number: 8121061
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AVANTI CORDIS 6F SHEATH; V-18 GUIDING CATHETER