MAUDE Adverse Event Report: AV-TEMECULA-CT ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM; SELF EXPANDING STENT SYSTEM

Catalog Number	1012532-100
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Thrombosis (2100); Diminished Pulse Pressure (2606)
Date of Event	05/15/2019
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: stent: innova 6.0x150, life stent 7.0x200, supera 6.0x150.The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The reported patient effect of thrombosis is listed in the absolute pro instruction for use, as a known patient effect associated with the use of the device.Based on the case information, a conclusive cause for the reported patient effects, 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.The supera stent is being filed under a separate medwatch report.
Event or Problem Description
It was reported that on (b)(6) 2019, after angiography and intravascular ultrasound (ivus), aspiration thrombectomy was performed.An absolute pro stent was placed in the right common iliac artery and a supera self expanding stent (ses) was placed in the right superficial femoral artery.Two non-abbott stents were also placed in the right leg.On (b)(6) 2019, no pulse could be identified on the patient's right leg so an angiography was performed that confirmed acute thrombotic occlusion in the supera and absolute pro stents.There was no treatment performed.Reportedly, the other non-abbott stents similarly resulted in acute thrombus occlusion.No treatment was performed; however, bypass is scheduled in the future.The patient outcome is reported as "not recovered".No additional information was provided.

• Brand Name: ABSOLUTE PRO VASCULAR 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: 8666785
• Report Number: 2024168-2019-04353
• Device Sequence Number: 2232373
• Product Code: NIO
• UDI-Device Identifier: 08717648175879
• UDI-Public: 08717648175879
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P110028
• 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): 06/04/2019

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: 11/30/2021
• Device Catalogue Number: 1012532-100
• Device Lot Number: 8121461
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2019
• Initial Report FDA Received Date: 06/04/2019
• 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: SEE H10 FOR CONCOMITANT MEDICAL PRODUCTS
• Outcome Attributed to Adverse Event: Other