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

Catalog Number	1012530-100
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Thrombosis (2100); Claudication (2550)
Date of Event	05/15/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device was not returned for evaluation.A review of the electronic lot history record (elhr) revealed no non-conformities associated with this lot.There was no reported device malfunction.The reported patient effects of allergic reaction and thrombosis are listed in the absolute pro instructions for use as known patient effects.Based on the case information and related record review, 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.
Event or Problem Description
It was reported that the procedure was performed to treat a de novo lesion in the external iliac artery with 100% stenosis.On (b)(6) 2018, the patient presented with intermittent claudication.An 8.0 x 100 mm absolute pro self-expanding stent system was successfully deployed.Post-implantation, the ankle brachial index (abi) became worse.Blood pressure of the ankle and brachial were measured and the computed tomography (ct) revealed acute in-stent occlusion [thrombosis].On (b)(6) 2018, the patient received a follow-up exam and the patient still had claudication.On (b)(6) 2018, a ct was performed on the patient due to symptoms from (b)(6) 2018 follow-up.On (b)(6) 2018, treatment was performed to treat the in-stent thrombosis.The thrombosis in the stent was aspirated and a non-abbott stent was implanted.The patient was prescribed doses of dual antiplatelet drug therapy (dapt), post-procedure.Reportedly, the physician suspected the possibility of metal allergy due to the acute occlusion [thrombosis] which was proven by drug lymphocyte stimulation allergy test given to the patient.The patient was given direct oral anticoagulants to treat the allergy.On (b)(6) 2018, the abi level was normal and the patient was discharged.There was no adverse patient sequela reported and no clinically significant delay in the procedure.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: 7887135
• Report Number: 2024168-2018-07262
• Device Sequence Number: 11275169
• Product Code: NIO
• UDI-Device Identifier: 08717648175732
• UDI-Public: 08717648175732
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/18/2018

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: 11/30/2018
• Device Catalogue Number: 1012530-100
• Device Lot Number: 5120761
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2018
• Initial Report FDA Received Date: 09/18/2018
• 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