MAUDE Adverse Event Report: AV-TEMECULA-CT XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT SYSTEM

Catalog Number 1009542-23

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

Patient Problems Angina (1710); Atrial Fibrillation (1729); Stenosis (2263)

Event Date 03/02/2015

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2014, the patient underwent a coronary stenting procedure with placement of a 3.5 x 23 mm xience v stent in the left main coronary artery/ostial circumflex artery and a 2.5 x 18 mm xience v stent and a 3.5 x 18 mm xience v stent in the distal circumflex artery.On (b)(6) 2015, the patient experienced angina and diagnostic coronary angiography was performed.In-stent restenosis was noted in the 3.5 x 23 mm xience v stent implanted in the left main coronary artery/ostial circumflex artery.Surgical evaluation was performed on (b)(6) 2015.On (b)(6) 2015, the patient underwent a coronary artery bypass graft procedure x2 with left internal mammary artery to left anterior descending artery and saphenous vein graft to the 1st obtuse marginal artery.On post operative day 2, the patient had a brief run of atrial fibrillation that was treated with intravenous amiodarone and converted back to sinus rhythm.The patient's condition resolved on (b)(6) 2015 and the patient was discharged to home.No additional information was provided.

Manufacturer Narrative

(b)(4).Concomitant medical products : stent: xience v (2.5x18, 3.5x18).Other: aspirin, clopidogrel.The stent remains in the patient and there was no reported device malfunction.A review of the lot history record revealed no non-conformances that would have contributed to the reported event.The reported patient effects of angina, atrial fibrillation and restenosis, as listed in the xience v everolimus eluting coronary stent system electronic instructions for use are known patient effects that may be associated with use of a coronary stent in native coronary arteries.Although 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 deficiency with respect to manufacturing, design or labeling.

• Brand Name: XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Type of Device: DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 462
• Manufacturer (Section G): CLONMEL, IRELAND REG# 9616693; abbott vascular; 26531 ynez road; temecula CA 92591 462
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 4636794
• MDR Text Key: 5759774
• Report Number: 2024168-2015-01657
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P070015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/04/2015

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: 12/12/2014
• Device Catalogue Number: 1009542-23
• Device Lot Number: 2120741
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/04/2015
• Initial Date FDA Received: 03/26/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2012
• 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
• Treatment: CONCOMITANT MEDICAL DEVICES
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 67 YR
• Patient Weight: 81