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

Catalog Number 1074250-23

Device Problem Occlusion Within Device (1423)

Patient Problems Nausea (1970); Reocclusion (1985); Stenosis (2263); Chest Tightness/Pressure (2463)

Event Date 11/16/2014

Event Type  Injury  

Event Description

It was reported that the patient reported with an acute myocardial infarction (ami).On (b)(6) 2014, the procedure was to treat a 100% stenosed lesion in the mildly tortuous left anterior descending (lad) artery.After placement of a non-abbott guide wire, pre-dilatation was performed with a 1.5x15mm non-abbott balloon dilatation catheter (bdc).The 2.5x23mm xience xpedition stent implant was successfully deployed at 10 atmospheres (atm).The procedure was completed without any reported device or procedure issues.Thrombolysis in myocardial infarction (timi) flow improved to timi 3 and the stent implant was noted to be well expanded by angiography.The procedure was completed without any reported device or procedure issues.Later on the same day of the procedure, the patient experienced nausea and chest discomfort.On (b)(6) 2014, angiogram revealed in-stent thrombosis of the deployed 2.5x23mm xience xpedition stent implant.After placement of a non-abbott guide wire, aspiration was performed and medicine was administered.However, timi flow was timi 2.Therefore, a non-abbott embolic protection device (epd) was placed and the vessel was dilated with a 2.5x15mm non-abbott bdc at 12 atm, restoring timi flow 3.The patient was discharged on (b)(6) 2014.There was no reported adverse patient sequela.There was no additional information provided.

Manufacturer Narrative

(b)(4).There was no reported device malfunction and the product was not returned.A review of the lot history record revealed no non-conformances that would have contributed to the reported event.Angina, ischemia, nausea, and thrombosis are listed in the xience xpedition everolimus eluting coronary stent systems instructions for use (ifu) as known patient effects of coronary stenting procedures.Based on the information reviewed, there is no evidence to indicate the presence of a product deficiency.

• Brand Name: XIENCE XPEDITION 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: 4327917
• MDR Text Key: 18636027
• Report Number: 2024168-2014-08178
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/19/2015
• Device Catalogue Number: 1074250-23
• Device Lot Number: 3013141
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2013
• 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