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

Catalog Number 42055200-120

Device Problems Material Separation (1562); Stretched (1601); Improper or Incorrect Procedure or Method (2017); Difficult or Delayed Activation (2577); Migration (4003)

Patient Problem Embolism/Embolus (4438)

Event Date 08/18/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).The customer reported the device is not returning.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

Event Description

It was reported that the supera stent system was advanced to the lesion without reported issue.After device deployment, the supera stent failed to release from the delivery system and during removal of the delivery system the stent moved from its intended location but remained partially in the lesion and stretched more than 10%.Additionally, the system was not locked during removal, resulting in the difficult separation of the stent from the delivery system, and the nose cone separating from the delivery system.After separation, the nose cone embolized to the anterior tibial artery and was surgically removed.There was no adverse patient sequela or a clinically significant delay in procedure.No additional information was provided.

Event Description

Subsequent to the previously filed report, the following information was received: the procedure was to treat the dissected moderately calcified proximal and mid superficial femoral artery.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 similar incidents and/or complaints from this lot.The supera instruction for use instructs: ¿following confirmed implantation of the supera stent, retract the thumb slide in a single motion to the starting position on the handle and rotate the system lock and deployment lock into the locked position, in line with the thumb slide.¿ the reported patient effect of embolism is listed in the supera instructions for use (ifu) as a known potential patient effect associated with peripheral percutaneous intervention.Based on the information provided, the reported difficulties and subsequent patient effects appear to be user/case related.Failing to retract and lock the thumbslide into place appears to be the likely cause for the reported difficulties encountered.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: 12450527
• MDR Text Key: 270777461
• Report Number: 2024168-2021-08033
• 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: 09/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Catalogue Number: 42055200-120
• Device Lot Number: 0090861
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention