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

Catalog Number S-65-100-120-P6

Device Problems Entrapment of Device (1212); Material Separation (1562)

Patient Problem Vessel Or Plaque, Device Embedded In (1204)

Event Date 10/30/2019

Event Type  Injury  

Manufacturer Narrative

Exemption number e2019001.The customer reported the delivery system was discarded, but 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 that the procedure was to treat a superficial femoral artery (sfa).After introducing a 6.5x100mm supera self-expanding stent delivery system into the anatomy, the tip of the stent broke off while attempting to deploy.The nose cone got caught at the end of the stent, however the stent was able to be deployed successfully.The physician did not have a snare device to remove the tip, so a second stent was deployed over the tip with a good result.The tip still remains in the anatomy.There was no clinically significant delay in the procedure and no adverse patient effects.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 identified no other incidents and/or complaints.The investigation determined that the reported difficulties were due to procedural circumstances.Based on the information provided, the tip detachment occurred due to the tip catching on the distal end of the stent during deployment.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: 9315282
• MDR Text Key: 166167715
• Report Number: 2024168-2019-13495
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08717648226281
• UDI-Public: 08717648226281
• 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: 01/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2020
• Device Catalogue Number: S-65-100-120-P6
• Device Lot Number: 8121461
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 100