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

Catalog Number 42045100-120

Device Problems Entrapment of Device (1212); Migration (4003)

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

Event Date 07/10/2021

Event Type  Injury  

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 performed to treat a lesion in the moderately calcified, moderately tortuous superficial femoral artery.A 4.5x100mm supera self-expanding stent system (sess) was advanced, and the stent was deployed.The sess faced resistance with the deployed stent, but after several attempts, it was possible to withdraw the sess so the tip was at the puncture site.However, the stent was inadvertently removed from its location with the sess.The patient was sent to surgery for removal of the sess and the stent was explanted.The patient was reportedly in good health post procedure.There were no adverse patient sequelae.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The reported entrapment of device and the reported migration were unable to be replicated in a testing environment as they were based on operational circumstances.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.As the thumb slide was noted returned at the distal end of the deployment lock, the investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that the reported entrapment was due to not retracting and locking the thumbslide to sheath the tip prior to removal; thus resulting in the tip catching the stent struts.Manipulation of the device resulted in the noted material separations (tip jacket, tip lumen) and ultimately resulted in the reported migration of the stent.The noted kinked outer sheath likely occurred due to handling or during packing for return analysis.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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: 12246027
• MDR Text Key: 264082442
• Report Number: 2024168-2021-06627
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 08/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Catalogue Number: 42045100-120
• Device Lot Number: 0071461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2021
• Date Manufacturer Received: 08/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention