MAUDE Adverse Event Report: ABBOTT VASCULAR SUPERA 6F; SELF EXPANDING PERIPHERAL STENT SYSTEM

Catalog Number 42075040-080

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/08/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was not returned for analysis.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 reported from this lot.It should be noted in the supera electronic instructions for use (ifu) indications, section 3.0 states: the supera peripheral stent system is indicated to improve luminal diameter in the treatment of patients with symptomatic de novo or restenotic native lesions or occlusions of the superficial femoral artery (sfa) and / or proximal popliteal artery with reference vessel diameters of 4.0 to 6.5 mm, and lesion lengths up to 140 mm.Therefore, the brachial vein graft is not an intended lesion site for the device.In this case, the brachial vein graft is not an intended for use site for the supera stent delivery system.It is possible that the stent shortening occurred because it was pushed forward during deployment in the brachial vein graft; however, this cannot be confirmed.The investigation was unable to confirm the reported shortened stent.It is possible that the stent shortening occurred because it was pushed forward during deployment in the brachial vein graft; however, this cannot 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 to treat a 100% restenosed brachial vein graft.A 7.5x40mm supera stent was deployed but it was noted that the stent shortened and unable to cover the entire lesion.Therefore another supera stent was used to successfully cover the rest of the lesion and complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: SUPERA 6F
• 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: 11076888
• MDR Text Key: 223748615
• Report Number: 2024168-2020-10947
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: SN
• 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: 12/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Catalogue Number: 42075040-080
• Device Lot Number: 0040361
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/03/2020
• 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