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

Catalog Number 1012534-100

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Arrhythmia (1721); Fatigue (1849); Hypersensitivity/Allergic reaction (1907); High Blood Pressure/ Hypertension (1908); Thrombosis (2100)

Event Date 12/31/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Product performance engineering reviewed the incident information, however, there was no reported device malfunction, the product was not returned, and the stent remains implanted in the patient.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 effects of hypertension and thrombosis are known observed and potential patient effects as listed in the absolute pro vascular instructions for use (ifu).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 design, manufacture or labeling of the device.

Event Description

It was reported that the patient presented at the hospital on (b)(6) 2016 with a black toe due to ischemia of the right superficial femoral artery (sfa).On (b)(6) 2016, a 6.0mm x 100mm x 135cm absolute pro vascular self-expanding stent system (sess) was implanted without issue to improve flow to the toe.On (b)(6) 2016, the patient experienced arrhythmia and high blood pressure and a blood clot was found in the toe.The patient was transferred to the intensive care unit (icu) for observation and was treated with intravenous blood thinner medication.This medication successfully resolved the arrhythmia, high blood pressure, and blood clot, and the patient was discharged the same day.The patient has since been experiencing a rash all over body and swollen lymph glands behind ear (both believed by the patient to be a possible hypersensitivity to the stent) and fatigue.No treatment for possible hypersensitivity has been administered to date.No additional information was provided.

• Brand Name: ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM
• Type of Device: SELF EXPANDING STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 6474171
• MDR Text Key: 72174804
• Report Number: 2024168-2017-02944
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 08717648176012
• UDI-Public: (01)08717648176012(17)190630(10)6071961
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Patient
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 04/07/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: 1012534-100
• Device Lot Number: 6071961
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/17/2017
• Initial Date FDA Received: 04/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 65 YR
• Patient Weight: 61