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

Catalog Number SE-07-100-080-6F

Device Problems Off-Label Use (1494); Defective Device (2588); Migration (4003)

Patient Problems Thrombosis (2100); Stenosis (2263)

Event Date 12/22/2020

Event Type  Injury  

Manufacturer Narrative

Estimated date.The stent remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

Event Description

It was reported that a 7.0 x 10 cm supera stent was implanted in the brachiobasilic fistula on (b)(6) 2016 due to partial thrombosis being noted.On (b)(6) 2020, after 4 years, the patient was re-admitted with thrombosis and on imaging the supera stent appeared to have shortened and the moved.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.The reported patient effects of thrombosis and stenosis are listed in the supera peripheral stent system instruction for use (ifu) as known potential patients effects associated with the use of a stent in the peripheral arteries and/or biliary tree.The supera ifu instructs: 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.The investigation is unable to determine the cause for the reported migration, and shortened stent.It is possible, that the stent was elongated during deployment, due to an undersized fistula, then shortened over time to its designed configuration.In addition, it is also possible that the off-label use of the system within a brachiobasilic fistula allowed the stent to migrate leading to the foreshortening.However, these could not be confirmed, because the scale of the cine images are unknown, and the stent was not returned for analysis.The cause of the thrombosis, stenosis, hospitalization, and additional therapy are related to the case circumstances.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.B6, d6a: corrected to actual date, no longer estimated date.

Event Description

Subsequent to the initial report, additional reported information indicates that the fistula thrombosis was confirmed via fistulogram and a balloon angioplasty and an unspecified stent was implanted to treat the thrombosis.There was no specific treatment provided to correct the stent foreshortening; however, an additional unspecified stent graft was implanted to treat the stent edge stenosis.The date the supera stent was implanted was (b)(6) 2016.

• 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: 11189848
• MDR Text Key: 227497341
• Report Number: 2024168-2021-00545
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 02/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2017
• Device Catalogue Number: SE-07-100-080-6F
• Device Lot Number: 5100961
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/03/2021
• Initial Date FDA Received: 01/18/2021
• Supplement Dates Manufacturer Received: 02/03/2021
• Supplement Dates FDA Received: 02/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Weight: 72