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

Catalog Number 1009542-15

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

Patient Problems Atrial Fibrillation (1729); Myocardial Infarction (1969); Stenosis (2263)

Event Date 02/11/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Concomitant medical products: stent: xience v (4.0x18, 3.5x12); aspirin, clopidogrel.The customer reported the device was discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that on (b)(6) 2012, the patient underwent a coronary stenting procedure.A 4.0 x 18 mm xience v stent and a 3.5 x 12 mm xience v stent were implanted in the left main/proximal left anterior descending artery complex and a 3.5 x 15 mm xience v stent in the proximal right coronary artery.On 02/11/2017, the patient experienced an episode of atrial fibrillation.On (b)(6) 2017, the patient experienced a myocardial infarction and unspecified treatment was provided.On (b)(6) 2017, coronary artery stenosis was noted.No additional information was provided.

Manufacturer Narrative

(b)(4).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.Myocardial infarction and stenosis are listed in the xience v everolimus eluting coronary stent system instructions for use as a known patient effects of coronary stenting procedures.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 and there is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

Subsequent to the initial 30-day medical device report, additional information was received, indicating that the atrial fibrillation was not related to the xience v stents or procedure.The 3.5 x 15 mm xience v stent implanted in the proximal right coronary artery was occluded.The patient underwent a surgical procedure on (b)(6) 2017 to treat an ascending aortic aneurysm and perform coronary artery bypass graft (cabg).No additional information was provided.

• 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 4628
• Manufacturer (Section G): CLONMEL, IRELAND REG# 9616693; 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: 6474338
• MDR Text Key: 72176783
• Report Number: 2024168-2017-02949
• 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: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/20/2014
• Device Catalogue Number: 1009542-15
• Device Lot Number: 2050341
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2012
• 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
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 69 YR
• Patient Weight: 113