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

Catalog Number 42065150-120

Device Problem Break (1069)

Patient Problems Pain (1994); Claudication (2550)

Event Date 12/24/2019

Event Type  Injury  

Manufacturer Narrative

The additional supera stent referenced is filed under a separate medwatch report number.The device was not returned for evaluation.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 and/or complaints from this lot.The investigation was unable to determine a cause for the reported stent fracture.It may be possible that the supera stent was subjected to stress/fatigue or repetitive movement due to anatomical conditions and location of the implant; however, this could not be confirmed.The additional patient effects and treatments including surgery were due to case circumstances.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

This event was initially reported through a presentation titled, ¿relining of gardener¿s stent fracture (supera tm stent) in popliteal artery¿.It was reported that on (b)(6) 2019, a percutaneous peripheral intervention was performed on the popliteal artery.Lesion preparation was performed via aspiration and rotarex thrombectomy.Following, a 6.5x100mm supera stent (42065100-120, 8080661) was implanted without a device issue.Post-dilatation was performed.On (b)(6) 2019, the 6.5x100mm supera stent had a fracture, almost separating into two pieces.The lumen remained patent.On (b)(6) 2019, the 6.5x100mm supera stent had a thrombotic total occlusion.On (b)(6) 2019, another percutaneous peripheral intervention was performed.Rotarex thrombectomy and a second supera stent, a 6.5x150mm supera stent (42065150-120, 9051561) was implanted without a device issue.Post-dilatation was performed.On (b)(6) 2019, the 6.5x150mm supera stent had fractured, almost separating into two pieces.Due to the supera stent fractures, the patient had experienced calf pain and claudication.On (b)(6) 2020, the patient had a femoral-tibial bypass.No additional information was provided regarding this issue.

Manufacturer Narrative

This report is being resubmitted to ensure the enclosed attachment can be easily opened by the fda.Na.

• 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
• MDR Report Key: 9780044
• MDR Text Key: 183882800
• Report Number: 2024168-2020-01937
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• PMA/PMN Number: P120020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/22/2020

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Catalogue Number: 42065150-120
• Device Lot Number: 9051561
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/06/2020
• Initial Date FDA Received: 03/03/2020
• Supplement Dates Manufacturer Received: 07/20/2020
• Supplement Dates FDA Received: 07/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 1 SUPERA STENT
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Weight: 63