MAUDE Adverse Event Report: AV-TEMECULA-CT XIENCE XPEDITION 48 EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT SYSTEM

Catalog Number 1070300-48

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

Patient Problems Angina (1710); Death (1802); Thrombosis (2100)

Event Date 11/27/2014

Event Type  Death  

Manufacturer Narrative

(b)(4).A cine of the procedure was received and reviewed by an abbott clinical specialist.The reviewer concluded that the cine confirmed the reported thrombus in the previously placed stent.The stent looked well approximated and post-dilatation was done during both visits to the cath lab.The reported patient effects of angina, thrombosis, and death, as listed in the xience xpedition everolimus eluting coronary stent system instructions for use (ifu) are known patient effects that may be associated with use of a coronary stent in native coronary arteries.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.

Event Description

It was reported that the 3.0x48 mm xience xpedition was deployed on (b)(6) 2014 in a patient that was experiencing an acute myocardial infarction.Thrombosuction and direct stenting was performed.The stent was confirmed visually to be fully apposed to the vessel wall, and the patient was reported to be doing well.Post-procedure the patient was experiencing chest pain.Angiography revealed thrombus, which was extracted followed by balloon angioplasty in the stented segment.The patient was discharged; however, later expired in another hospital.No additional information was provided.

Manufacturer Narrative

(b)(4).The stent remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

• Brand Name: XIENCE XPEDITION 48 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: 4358276
• MDR Text Key: 12928710
• Report Number: 2024168-2014-08467
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/20/2017
• Device Catalogue Number: 1070300-48
• Device Lot Number: 4051341
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/18/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2014
• 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): Death