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

Model Number S-55-150-120-P6

Device Problem Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/27/2020

Event Type  Injury  

Manufacturer Narrative

Estimated date of event.Estimated date of implant.The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history of the reported lot revealed no other complaints.The investigation was unable to determine a cause for the reported stent shortening.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Literature attached: "endoscopic findings of an excessively compressed interwoven nitinol supera stent".

Event Description

It was reported through a research presentation titled: "endoscopic findings of an excessively compressed interwoven nitinol supera stent." identifying a 5.5x150mm supera stent.The procedure was to treat a chronic total occlusion of the left superficial femoral artery with severe calcification.The supera stent was deployed without issue.After the stent was released from its sheath, compression of the supera stent was observed on angiography.Subsequently, post-dilatation was performed with a 6.0×150-mm high-pressure non-abbott balloon.Final angiogram and intravascular ultrasound indicated an acceptable result.A week later, the supera stent remained compressed with the appearance of a spider nest.No further treatment was reported.There was no adverse patient effects or clinically significant delay.No additional information was provided.

Manufacturer Narrative

This report is being resubmitted to ensure the enclosed attachment can be easily opened by the fda.(b)(4).

• Brand Name: SUPERA PERIPHERAL 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: 9963553
• MDR Text Key: 189705173
• Report Number: 2024168-2020-03675
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08717648226168
• UDI-Public: 08717648226168
• Combination Product (y/n): N
• PMA/PMN Number: P120020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup
• Report Date: 07/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Model Number: S-55-150-120-P6
• Device Catalogue Number: S-55-150-120-P6
• Device Lot Number: 8073061
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 84 YR
• Patient Weight: 84