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

Catalog Number 1009539-18

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

Patient Problems Cardiac Arrest (1762); Death (1802); Myocardial Infarction (1969); Respiratory Distress (2045)

Event Date 04/06/2014

Event Type  Death  

Event Description

Subsequent to the initial report, the following was received: the patient did not experience a myocardial infarction.

Manufacturer Narrative

(b)(4).

Event Description

It was reported that on (b)(6) 2012 two xience v stents were successfully implanted, one in the left main and one in the mid left anterior coronary arteries.On (b)(6) 2014, per electrocardiogram, changes were seen which was diagnosed as a myocardial infarction (mi) and the patient was hospitalized.At some point during hospitalization, the patient was intubated.Because the patient was 'do not resuscitate' status, the patient was extubated and put on comfort measures only, which included administration of morphine.On 04/08/2014, the patient died from cardiac arrest.There was no additional information provided.

Manufacturer Narrative

(b)(4).It is indicated that the device is not returning for evaluation; therefore a failure analysis of the complaint device could not be completed.A review of the lot history record revealed no non-conformances that would have contributed to the reported event.There was no reported device malfunction.Myocardial infarction and death are listed in the xience v everolimus eluting coronary stent systems instructions for use (ifu) as known patient effects of coronary stenting procedures.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.Based on the information reviewed, there is no evidence to indicate the presence of a product deficiency.

• 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: 4081691
• MDR Text Key: 4925115
• Report Number: 2024168-2014-05812
• 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,Followup
• Report Date: 08/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/15/2014
• Device Catalogue Number: 1009539-18
• Device Lot Number: 2032841
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/25/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2012
• 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: STENT: XIENCE V 3.0X18MM
• Patient Outcome(s): Death
• Patient Age: 86 YR
• Patient Weight: 76