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

Model Number	S-55-100-120-P6
Medical Device Problem Codes	Difficult or Delayed Activation (2577); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event has been estimated.Implant date has been estimated.The device was not returned for evaluation.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.Based on the information provided a cause for the difficulty could not be determined.It may be possible that the delivery system was pushed forward during deployment causing the stent to invaginate; however, this could not be confirmed.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported through a research article identifying the supera stent that may be related to stent invagination and difficult deployment due to the complex deployment system.The physician applied excessive push of the deployment catheter to avoid stent elongation, but this may have contributed to the stent invagination.Details are listed in the attached article, titled, "invagination of an interwoven nitinol stent during femoropopliteal placement.".
Additional Manufacturer Narrative
This report is being resubmitted to ensure the enclosed attachment can be easily opened by the fda.

• Brand Name: SUPERA SELF-EXPANDING 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: 9756436
• Report Number: 2024168-2020-01777
• Device Sequence Number: 11313870
• Product Code: NIP
• UDI-Device Identifier: 08717648226120
• UDI-Public: 08717648226120
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P120020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2020

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
• Operator of Device: Health Professional
• Device Model Number: S-55-100-120-P6
• Device Catalogue Number: S-55-100-120-P6
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/03/2020
• Supplement Date Received by Manufacturer: 07/20/2020
• Initial Report FDA Received Date: 02/26/2020
• Supplement Report FDA Received Date: 07/30/2020
• 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: Required Intervention
• Patient Age: 60 YR