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

Catalog Number 1070350-38

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

Patient Problems Cardiac Arrest (1762); Thrombosis (2100); Ventricular Fibrillation (2130); Ventricular Tachycardia (2132)

Event Date 11/04/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Based on the case information and related record review, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.The reported patient effects of thrombosis, ventricular tachycardia, and ventricular fibrillation are listed in the xience xpedition everolimus eluting coronary stent system instructions for use as known patient effects of coronary stenting procedures.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

The procedure was to treat a lesion in the proximal left anterior descending coronary artery (lad).On (b)(6) 2016, a 3.5x38mm xience xpedition stent was implanted.On (b)(6) 2016, the patient presented with ventricular tachycardia, ventricular fibrillation, and cardiac arrest.Angiography confirmed in-stent thrombosis.A non-abbott device was used to suction the thrombosis and a 3.75x15mm nc trek and a 3.75x15mm non-abbott device were used to successfully finish the procedure.It was suspected that the patient had a plavix resistance and the patient was unconscious.There was no clinically significant delay in the procedure.No additionally information was provided.

• 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 4628
• Manufacturer (Section G): CLONMEL, IRELAND REG# 9616693; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 6090898
• MDR Text Key: 59552792
• Report Number: 2024168-2016-07798
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648158131
• UDI-Public: (01)08717648158131(17)190509(10)6050341
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 11/09/2016

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: 05/09/2019
• Device Catalogue Number: 1070350-38
• Device Lot Number: 6050341
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/04/2016
• Initial Date FDA Received: 11/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2016
• 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; Life Threatening; Required Intervention
• Patient Age: 68 YR