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

Model Number S-50-120-120-P6

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Stenosis (2263)

Event Date 09/01/2020

Event Type  Injury  

Manufacturer Narrative

Date of event will be estimated as (b)(6) 2020.Date of implant has been estimated.The device was not returned for evaluation.A review of the lot history record of the reported lot could not be conducted because the lot number was not provided.The reported patient effects of stenosis and pain are listed in the supera peripheral stent system instructions for use as potential adverse effects of peripheral percutaneous intervention.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.However, the treatment appears to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.The additional supera stent reported is captured under a separate medwatch report number.Article titled "a case of restenosis 8 months after supera stenting using optical coherence tomography and angioscopy".

Event Description

It was reported that the patient had two supera self expanding stents (ses) implanted about eight months before returning to the hospital after having noticed resting pain in the left lower extremity.Initial imaging revealed in-stent restenosis of the 5x60 mm and 5x120 mm supera ses in the previously treated femoropopliteal artery (fpa) and a lesion in the posterior tibial artery, as indicated by superficial ultrasound.Optical coherence tomography (oct) was performed and found that most of the restenotic plaque was composed of fibrous tissue, there was no malposition of the stent, the stent was completely covered with neointima, and micro vessels were present in the fibrous tissue.Angioscopic findings included no red or white thrombi, and yellowish plaque of grade 3.After observation of the lesion, endovascular therapy (evt) was continuously performed.The in-stent restenosis division of the fpa lesion was treated with balloon treatment by a 4.0 mm noncompliant balloon.The left posterior tibial artery was treated with a 2.0 mm noncompliant balloon, and the final angiogram showed good dilation of the fpa and posterior tibial artery, and the procedure was completed.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
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 12606312
• MDR Text Key: 276655245
• Report Number: 2024168-2021-09073
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08717648211775
• UDI-Public: 08717648211775
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P120020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: S-50-120-120-P6
• Device Catalogue Number: S-50-120-120-P6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 85 YR