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

Catalog Number 42045080-120

Device Problems Off-Label Use (1494); Difficult or Delayed Activation (2577); Defective Device (2588)

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

Event Date 10/04/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was not returned for evaluation.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history of the reported lot revealed no other complaints reported from this lot.It should be noted that the indications for use listed in the super instruction for use (ifu) states: the supera peripheral stent system is indicated for peripheral vascular use following failed percutaneous transluminal angioplasty (pta) and palliative treatment of biliary strictures produced by malignant neoplasms.In this case, it could not be determined if using the supera in the radiocephalic arteriovenous fistula caused or contributed to the difficulties.The investigation was unable to determine a definitive cause for the reported difficulties.It is possible that the distal sheath of the delivery system was entrapped or bent in the anatomy such that the ratchet was unable to properly engage the stent resulting in partial deployment.Additionally, it may be possible that forward/pushing movement of the supera delivery system during stent deployment caused the stent to shorten once released; however, this could not be confirmed.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

It was reported that the procedure was performed to treat a lesion in the radiocephalic arteriovenous fistula.A 5mm non-abbott balloon was used for pre-dilatation.A 4.5x80mm supera self-expanding stent system (sess) was advanced, and the stent partially deployed.With manipulation, the stent was fully implanted but was noted to be slightly shortened and compressed.The patient is fine.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

• 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: 12747533
• MDR Text Key: 280085432
• Report Number: 2024168-2021-09955
• 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
• Report Date: 11/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Catalogue Number: 42045080-120
• Device Lot Number: 0062561
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/11/2021
• Initial Date FDA Received: 11/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1