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

Catalog Number UNK SUPERA

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

Patient Problems Stenosis (2263); Obstruction/Occlusion (2422); Vascular Dissection (3160); Thrombosis/Thrombus (4440)

Event Date 10/01/2018

Event Type  Injury  

Event Description

It was reported in a research article that the supera self expanding stent (ses) was used in the stella supera study to evaluate 2 year outcomes of the supera stent in the treatment of long femoropopliteal lesions in patients with symptomatic peripheral artery disease.The supera stent was implanted in 48 symptomatic patients, 78% of whom had total occlusions.In cases with severe recoil, focal dilation was performed.Follow up was performed at 30 days, 6 months, 12 months and 24 months.The average supera stent elongation was 6.8%.There were 8 cases of in-stent restenosis and in-stent thrombosis.Six patients required revascularization and open surgical repair with venous bypass performed in 2 cases and endovascular treatment in 4 cases.No stent fracture or amputation occurred.Overall, there was a statistically significant improvement of mobility, pain and anxiety and a statistically significant improvement of quality of life among all patients.Death occurred in three patients; however, it was not related to the procedure or device.Two were due to cancer, and one due to cardiovascular disease.Additional information can be found in the attached article titled, "treatment of long femoropopliteal lesions with self-expanding interwoven nitinol stent: 24 month outcomes of the stellasupera trial:".

Manufacturer Narrative

B3: date of event estimated.D6a - implant date estimated as (b)(6) 2016.D4: the udi is unknown because the part/lot number were not provided.The device was not returned for analysis.A review of the lot history record and similar incident review of the reported lot could not be conducted because the part and lot number were not provided.The reported patient effects of stenosis, occlusion, thrombosis, and dissection, are listed in the supera peripherial stent system instructions for use as potential adverse effects of peripheral percutaneous intervention.A conclusive cause for the reported stenosis, occlusion, thrombosis, intimal dissection, and the relationship to the product, if any, cannot be determined.The treatment(s) appear 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.Literature attachment.Article titled, 'treatment of long femoropopliteal lesions with self-expanding interwoven nitinol stent: 24 month outcomes of the stellasupera trial'.

• Brand Name: SUPERA
• 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: 18279486
• MDR Text Key: 329889573
• Report Number: 2024168-2023-13558
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P120020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/06/2023

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK SUPERA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/15/2023
• Initial Date FDA Received: 12/06/2023
• 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): Required Intervention; Hospitalization
• Patient Age: 72 YR
• Patient Sex: Male