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

Catalog Number 1009528-28

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

Patient Problems Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Ischemia (1942); Ventricular Fibrillation (2130); Ventricular Tachycardia (2132); Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Date 12/19/2018

Event Type  Death  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The stent remains in the patient and there was no device malfunction reported.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this event.The reported patient effect of death, hypotension, ventricular fibrilation, ventricular tachycardia, cardiac tamponade, pericardial effusion are listed in the xience v international instructions for use as known patient effects.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 issue with respect to the design, manufacture, or labeling of the device.

Event Description

It was reported that the mildly calcified and tortuous de novo lesion with 80% stenosis in the mid left anterior descending coronary artery was predilated then stented with the 2.75x28 mm xience v at 11 atmospheres.Hypotension and timi 2 flow occurred."ionotropes" and intracoronary nicorandil were administered.After 10 minutes hypotension occurred again; blood pressure was 60/40mm hg.A 2d echocardiogram showed a pericardial effusion with tamponade.The patient had multiple episodes of ventricular tachycardia and ventricular fibrillation (vt/vf).Resuscitation attempts were performed, but the patient could not be revived and the patient was declared dead.In the opinion of the physician, the xience v stent did not cause/contribute to the pericardial effusion and subsequent patient death.There were no device issues reported with the xience v stent, but the cause of the pericardial effusion is unknown.No additional information was provided.

• 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 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: 8256910
• MDR Text Key: 133355408
• Report Number: 2024168-2019-00397
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P070015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 01/17/2019

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: 11/22/2019
• Device Catalogue Number: 1009528-28
• Device Lot Number: 7111341
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/26/2018
• Initial Date FDA Received: 01/17/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2017
• 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: GUIDE WIRE: RUNTHROUGH
• Patient Outcome(s): Death