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

Catalog Number 1011734-33

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

Patient Problems Angina (1710); Ischemia (1942); Stenosis (2263); Test Result (2695)

Event Date 02/28/2014

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2013, the patient underwent a stenting procedure with placement of a 3.0 x 33 mm xience prime stent in the left main/proximal circumflex artery, a 4.0 x 28 mm xience v stent in the left main, and a 3.5 x 33 mm xience prime stent in the left main/proximal left anterior descending artery.On (b)(6) 2014, an abnormal stress test was performed, which noted stable angina and ischemia.In-stent restenosis was noted in all three stents implanted in the left main complex and on (b)(6) 2014, a revascularization procedure was performed in the left main artery, proximal left anterior descending artery and proximal circumflex artery.The patient condition resolved on (b)(6) 2014.No additional information was provided.

Manufacturer Narrative

(b)(4).The additional xience v and xience prime devices referenced are being filed under separate medwatch reports.It is indicated that the device is not returning for evaluation; therefore, a failure analysis of the complaint device could not be completed.The reported patient effects of angina, ischemia, and restenosis, as listed in the xience prime everolimus eluting coronary stent system electronic instructions for use, are known patient effects that may be associated with the use of coronary stents.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 PRIME LL 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: 3781680
• MDR Text Key: 4442498
• Report Number: 2024168-2014-02710
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110019
• 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: 04/11/2014

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: 03/13/2014
• Device Catalogue Number: 1011734-33
• Device Lot Number: 202234Y
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/11/2014
• Initial Date FDA Received: 04/30/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2012
• 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: STENTS: XIENCE PRIME 3.0X33MM, XIENCE V 4.0X28
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 58 YR
• Patient Weight: 65