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

Catalog Number UNK SUPERA

Device Problems Material Separation (1562); Activation Failure (3270)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/01/2020

Event Type  Injury  

Manufacturer Narrative

Estimated date of event is (b)(6) 2020.The di number is not known as the part and lot number were not reported.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 procedure was performed to treat a lesion with mild calcification, no tortuosity, and mild stenosis in the superficial femoral artery.Pre-dilation was performed with an unspecified balloon and an unknown supera stent delivery system (sds) was advanced.The supera stent only partially deployed before becoming stuck and preventing complete deployment.There was no issue with the thumbslide mechanism.Therefore, it was decided to retrieve the delivery system with the partially deployed stent.Although no resistance was reported, angiography showed that a piece of the supera stent had separated at the iliac bifurcation.The groin was then opened and the separated part of supera was removed with a surgical tie without any complications.There was no hemorrhage from the iliac artery.A delay was reported.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.The lot history record (lhr) for this product could not be reviewed and a similar complaint query could not be performed because the product was not returned for evaluation and the part and lot numbers were not reported.The investigation was unable to determine a cause for the reported difficulties.It may be possible that the distal sheath of the delivery system was entrapped or bent in the anatomy preventing the ratchet from engaging the stent properly and preventing the stent from fully releasing from the delivery system.Additionally, it may be possible that the supera stent was subjected to stress/force during removal causing the distal end of the stent to separate; however, this could not be confirmed.The surgical procedure to remove the separated portion of stent and delay in the procedure were due to circumstances of the procedure.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Na.

• 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: 10861792
• MDR Text Key: 216906495
• Report Number: 2024168-2020-09666
• 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: 11/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK SUPERA
• Device Lot Number: UNKNOWN SUPERA
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention