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

Catalog Number UNK SUPERA

Device Problems Stretched (1601); Defective Device (2588)

Patient Problems Perforation of Vessels (2135); Vascular Dissection (3160)

Event Date 03/01/2020

Event Type  Injury  

Manufacturer Narrative

B3: date of event has been estimated the device was not returned for evaluation.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 dissection and perforation are listed in the supera peripheral stent system instructions for use (ifu) as a potential adverse event.The investigation determined a conclusive cause for the reported stretched-stent and the reported defective device-shortened cannot be determined.A conclusive cause for the reported dissection and perforation, and the relationship to the product, if any, cannot be determined.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 deaths reported in the article are being captured under a separate medwatch report number.Literature attachment: article title: drug coated balloon improves outcomes of sub-optimal supera deployment in the intermediate termna.

Event Description

It was reported in a research article that sub optimal deployment of a supera stent has been shown to increase the rate of clinically driven target lesion revascularization (tlr).Supera stents were implanted in the femoral-popliteal arteries in de-novo and restenotic lesions.The purpose of this study was to assess the outcomes of clinically driven re-intervention, amputations and mortality in relation to use of a drug coated balloon as vessel preparation in different deployment conditions of supera stents (including nominal, elongated and compressed).There was death, amputation, dissection, perforation, target lesion revascularization, and elongated and condensed stent deployment requiring intervention.Vessel preparation with a drug coated balloon may reduce tlr regardless of supera deployment status.Additional details can be found in the attached article "drug coated balloon improves outcomes of sub-optimal supera deployment in the intermediate term".

• 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: 18277817
• MDR Text Key: 329862124
• Report Number: 2024168-2023-13538
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P120020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: 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

• Date FDA Received: 12/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK SUPERA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2023
• 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: 71 YR
• Patient Sex: Female