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

Model Number	S-50-030-120-P6
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Stenosis (2263)
Date of Event	07/03/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Dates of event: estimated dates.The device was not returned for analysis as the stent remains in the patient.The lot history record (lhr) for this product could not be reviewed and a similar complaint query could not be performed because the product was not returned for evaluation and the lot number was not reported.The reported patient effect of restenosis is listed in the supera instructions for use as a known potential patient effect.Based on the reported information, a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.The surgical procedure was related to case circumstances.There is no indication of a product quality issue with respect to manufacture, design or labeling.Literature attachment: pathology and multimodality imaging of acute and chronic femoral stenting in humans.The other supera referenced as case ten in the article is being filed under a separate medwatch report number.
Event or Problem Description
It was reported that the 5.0x30 mm supera stent was implanted in the superficial femoral artery to treat the patient with intermittent claudication.300 days after the implant procedure, the patient had in-stent restenosis.This was a patient referenced as case six in the article titled, pathology and multimodality imaging of acute and chronic femoral stenting in humans.
Additional Manufacturer Narrative
This report is being resubmitted to ensure the enclosed attachment can be easily opened by the fda.

• Brand Name: SUPERA PERIPHERAL STENT SYSTEM
• Common Device Name: SELF EXPANDING PERIPHERAL STENT SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9842533
• Report Number: 2024168-2020-02520
• Device Sequence Number: 2886226
• Product Code: NIP
• UDI-Device Identifier: 08717648211874
• UDI-Public: 08717648211874
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P120020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: literature
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: S-50-030-120-P6
• Device Catalogue Number: S-50-030-120-P6
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/25/2020
• Supplement Date Received by Manufacturer: 07/20/2020
• Initial Report FDA Received Date: 03/17/2020
• Supplement Report FDA Received Date: 07/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Disability
• Patient Age: 67 YR