MAUDE Adverse Event Report: AV-TEMECULA-CT SUPERA SELF-EXPANDING STENT SYSTEM; SELF EXPANDING STENT SYSTEM

Catalog Number	S-50-060-120-P6
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Stenosis (2263)
Date of Event	05/21/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Date of event: dates estimated.The device remains implanted in the patient.The lot history record (lhr) could not be reviewed and a similar incident 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 associated with use of the device.A conclusive cause for the stent fracture and stenosis cannot be determined.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 that approximately 8 months post implant of a 5 x 60 mm supera treating a subtotal occlusion of the popliteal artery, the patient presented with right limb claudication, and absent pulses of the right foot.Radiography was performed, noting the stent was fractured and re-stenosed/occluded.Surrounding vessels were patent.Considering that recanalization of the vessel was not possible, a popliteal to popliteal bypass was performed.The procedure was successful and post-operative course uneventful.Details are listed in the attached article, titled fracture of a supera interwoven nitinol stent after treatment of popliteal artery stenosis.Please see article for additional information.

• Brand Name: SUPERA SELF-EXPANDING STENT SYSTEM
• Common Device Name: SELF EXPANDING STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 8728469
• Report Number: 2024168-2019-05005
• Device Sequence Number: 11209553
• Product Code: NIP
• UDI-Device Identifier: 08717648211744
• UDI-Public: 08717648211744
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P120020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: foreign,literature
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 06/24/2019

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 Catalogue Number: S-50-060-120-P6
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2019
• Initial Report FDA Received Date: 06/24/2019
• 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: 60 YR