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 Intimal Dissection (1333); Headache (1880); Pain (1994)

Event Date 01/07/2015

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2015, a 3.5x23mm xience v stent was implanted in the mid left anterior descending (lad) coronary artery.Following, a distal edge dissection was noted and treated with a 3.0x15mm xience v stent.Post procedure, the patient complained of non-cardiac chest pain and a headache.Medication was provided for both.Reportedly, the chest pain and headache were not serious.On (b)(6) 2015, the headache resolved without sequela and the patient was discharged home.There was no additional information provided.

Manufacturer Narrative

(b)(4).Lab data: (b)(6) 2015 (12:15): troponin i=0.005 ng/ml, upper reference limit 0.04; (b)(6) 2015: ck=42 u/l, normal upper limit 223; (b)(6) 2015: ck-mb=1.3 ng/ml, normal upper limit 5.0.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.The reported patient effects of pain, headache and dissection, as listed in the xience v everolimus eluting coronary stent system electronic instructions for use (ifu) 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.Based on the reviewed information, no product deficiency was identified.

• 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: 4443709
• MDR Text Key: 5379325
• Report Number: 2024168-2015-00367
• 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: 01/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/09/2016
• Device Catalogue Number: 1009542-23
• Device Lot Number: 4013141
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2014
• 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
• Patient Age: 51 YR
• Patient Weight: 120