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

Catalog Number 42045150-120

Device Problem Material Separation (1562)

Patient Problem Ischemia (1942)

Event Date 04/16/2020

Event Type  Injury  

Manufacturer Narrative

The device is expected to be returned for evaluation.It has not yet been received.A follow report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was performed to treat a heavily calcified, moderately tortuous tibial peroneal artery.A 4.5x150 6f supera self-expanding stent delivery system was used but had a tip separation.The tip was removed via surgery.The patient then experienced chronic foot ischemia.The treatment was not specified.There was no adverse patient sequela reported.No additional information was provided.

Event Description

Additional information received subsequent to filing the initial report: the stent was implanted in the target lesion.The chronic foot ischemia was treated after surgery.The patient went through conservative therapy (medication) with the possibility of revascularization later on.No additional information was provided.

Manufacturer Narrative

Visual analysis was performed on the returned device.The reported tip detachment was confirmed.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 complaints reported from this lot.The reported patient effect of ischemia is listed in the supera instructions for use as a known potential adverse effect associated with peripheral percutaneous intervention.Based on the information provided, a conclusive cause for the reported tip detachment and ischemia could not be determined.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• 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: 10026418
• MDR Text Key: 189926070
• Report Number: 2024168-2020-04113
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 07/31/2020

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: 03/31/2021
• Device Catalogue Number: 42045150-120
• Device Lot Number: 9042461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2020
• Initial Date Manufacturer Received: 04/16/2020
• Initial Date FDA Received: 05/05/2020
• Supplement Dates Manufacturer Received: 07/20/2020
• Supplement Dates FDA Received: 07/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Weight: 90