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

Catalog Number 42055200-080

Device Problems Difficult to Remove (1528); Difficult or Delayed Activation (2577); Defective Device (2588); Difficult to Advance (2920); Material Deformation (2976)

Patient Problem Occlusion (1984)

Event Date 02/26/2020

Event Type  Injury  

Manufacturer Narrative

The stent is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all additional relevant information.The other supera is being filed under a separate medwatch report #.The additional device is being filed under a separate medwatch report#.

Event Description

It was reported that the procedure was performed to treat a superficial femoral artery (sfa).About 4 months ago, the patient had a non-abbott stent implanted which was massively over dilated to 7mm.The ends had crimped slightly, and the stent became occluded.On (b)(6) 2020, the vessel was prepared using a 6-french non-abbott atherectomy device and a 5.5x200mm armada 18 balloon.During deployment of the 5.5x200mm supera stent, the stent became damaged (assumed to be invaginated) as it reached the previously implanted stent.The physician stopped the deployment and pulled back slightly to allow the stent to get back to normal but was unsuccessful as the stent became stuck with the sheath.After some pulling, the stent fully deployed.The stent was noted to be short and therefore a second same size supera stent was deployed overlapping the first supera stent in the proximal sfa.Images of the section of the damaged stent did not look great and was treated with post-plasty however it remained the same.Blood flow was brisk but within 24 hours, both supera stents had occluded.An above knee bypass procedure was done on (b)(6) 2020.Only the damaged supera stent (the first implanted) was explanted and it was then confirmed that the stent was twisted on itself and completely distorted in certain areas and not invaginated as previously thought.There was no adverse patient sequela reported.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 from this lot.The reported patient effect of occlusion is listed in the supera instructions for use as a known potential patient effect of peripheral percutaneous intervention.Based on the information provided, a conclusive cause for the reported difficulties and subsequent patient effect could not be determined.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: 9835538
• MDR Text Key: 183535945
• Report Number: 2024168-2020-02455
• 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: 04/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2020
• 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 Catalogue Number: 42055200-080
• Device Lot Number: 9080861
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 5.5X200 SUPERA STENT; 6F CORDIS BRITE-TIP SHEATH; FLUENCY STENT; 5.5X200 SUPERA STENT; 6F CORDIS BRITE-TIP SHEATH; FLUENCY STENT
• Patient Outcome(s): Hospitalization; Required Intervention; Disability