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

Catalog Number UNK SUPERA

Device Problem Material Separation (1562)

Patient Problem Claudication (2550)

Event Date 04/06/2020

Event Type  Injury  

Manufacturer Narrative

Implant date - estimated.The stent remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

Event Description

It was reported that approximately one-year post implantation of a supera stent in the popliteal artery, the patient experienced claudication and was hospitalized.It was noted that the stent was circumferentially fractured.The patient remains active and, other than medication, does not want any additional treatment.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.The lot history record could not be reviewed and a similar complaint query could not be performed because the product was not returned for evaluation and the part and lot numbers were not reported.The reported patient effect of worsening claudication is listed in the supera instructions for use as a known potential patient effect of peripheral percutaneous intervention.The investigation was unable to determine a cause for the reported stent fracture.The additional patient effect, treatment with medication and hospitalization are due to case circumstances.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: 10026206
• MDR Text Key: 190101158
• Report Number: 2024168-2020-04110
• 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: 05/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2020
• 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
• Date Manufacturer Received: 05/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 40 YR