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

Catalog Number	S-55-080-120-P6
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	04/25/2019
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.Concomitant medical products: guide wire: command14; other: destination 6f; stent: eluvia (7.0x40), viabahn (6.0x50).There was no reported device malfunction and the product was not returned as the stent remains in the anatomy.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Based on the case information and related record review, a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.The reported patient effect of perforation is listed in the supera instructions for use, as known potential patient effect associated with the use of the device.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that the procedure was performed to treat a 75% stenosed, narrow, and non-calcified de novo lesion in the common femoral artery.On (b)(6) 2019, the patient underwent endovascular treatment (evt) with contralateral access and a popliteal puncture.A 7x40 non-abbott stent was deployed; however, two days later acute arterial occlusion occurred.Angiography was performed and confirmed stenosis in the previously deployed stent and popliteal puncture.A 6x50mm non-abbott stent was placed at the site of the previously deployed non-abbott stent and a 5.5x80mm supera self-expanding stent was deployed in between the p2 and p1.Following deployment of the supera stent a vascular rupture was observed at the site of the popliteal puncture.A 4x30mm non-abbott stent was deployed to successfully stop the bleeding.There was no adverse patient sequela and no clinically significant delay in the procedure.No additional information was provided.

• 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: 8675930
• Report Number: 2024168-2019-04492
• Device Sequence Number: 14081016
• Product Code: NIP
• UDI-Device Identifier: 08717648226106
• UDI-Public: 08717648226106
• 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,distri
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 06/06/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: S-55-080-120-P6
• Device Lot Number: 8052261
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2019
• Initial Report FDA Received Date: 06/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CONCOMITANT MEDICAL PRODUCTS
• Outcome Attributed to Adverse Event: Required Intervention