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

Catalog Number	S-65-150-120-P6
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis (2100)
Date of Event	02/27/2019
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.The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot and relabeled lot that would have contributed to this event.The reported patient effect of thrombosis is listed in the supera peripheral stent systems, instructions for use, as a known patient effect of the stenting procedures.A conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that a 6.0x150 mm supera self expanding stent (ses) was implanted and one day later the patient experienced thrombosis.The patient was asymptomatic; however the physician suspected thrombosis as the area was the same color as before the procedure.Angiography was performed to confirm the thrombosis.The thrombosis was treated with aspiration and thrombectomy and urokinase was administered.The patient has improved.There was no reported clinically significant delay in the procedure.No additional information was provided.
Event or Problem Description
Subsequent to the previously filed report, the following information was received: the vessel was prepared with a 2.0x150 mm and 5.0x150 mm percutaneous transluminal angioplasty (pta) catheters and finally a 5.0x120mm drug coated balloon (dcb) for one minute at 12 atmospheres.The supera stent was implanted in the distal superficial femoral artery.No additional information was provided.
Additional Manufacturer Narrative
Internal file number - (b)(4).

• 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: 8413928
• Report Number: 2024168-2019-01959
• Device Sequence Number: 303358
• Product Code: NIP
• UDI-Device Identifier: 08717648226328
• UDI-Public: 08717648226328
• 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,Followup
• Report Date (Section B): 04/01/2019

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: 05/31/2020
• Device Catalogue Number: S-65-150-120-P6
• Device Lot Number: 8062161
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/28/2019
• Supplement Date Received by Manufacturer: 03/15/2019
• Initial Report FDA Received Date: 03/12/2019
• Supplement Report FDA Received Date: 04/01/2019
• 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: Required Intervention