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

Catalog Number 1011708-15

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

Patient Problems Angina (1710); Cardiac Arrest (1762); Death (1802)

Event Date 12/05/2017

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.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Event Description

It was reported the patient presented with chest discomfort on (b)(6) 2017 and angiography was performed on (b)(6) 2017.On (b)(6) 2017 a procedure was performed to treat a concentric, de novo lesion in the proximal left anterior descending coronary artery.Pre-dilatation was performed with a 2.5 x 12 mm nc trek balloon and a 2.75 x 15 mm xience prime stent was implanted.Timi ii flow was achieved.Post procedure the patient was administered medication.However, when the patient was sent to intensive care unit (icu), the patient experienced angina and cardiac arrest.Cardiopulmonary resuscitation (cpr) was performed and cardiac emergency drugs administered, but the patient health declined and the patient died that same day.No autopsy was performed.No additional information was provided.

Manufacturer Narrative

(b)(4).The device was not returned for evaluation.The reported patient effects of angina and death are listed in the xience prime everolimus eluting coronary stent system, instructions for use as known patient effects of coronary stenting procedures.A cine was received and reviewed by an abbott vascular clinical specialist.The reviewer concluded that angiographic imaging post deployment of the stent shows a clinically acceptable flow of blood rated as timi iii, which is defined as normal flow which fills the distal coronary bed completely.After review of the imaging and information provided, there appears to be no product defect or performance issues as they relate to the implanted stent and / or the process of stent implantation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.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 manufacture, design or labeling of the device.

• Brand Name: XIENCE PRIME 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: 7136596
• MDR Text Key: 95445768
• Report Number: 2024168-2017-10017
• 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: company representative,distri
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/23/2018

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: 08/09/2020
• Device Catalogue Number: 1011708-15
• Device Lot Number: 7080141
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2017
• Initial Date FDA Received: 12/20/2017
• Supplement Dates Manufacturer Received: 02/21/2018
• Supplement Dates FDA Received: 02/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2017
• 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
• Patient Outcome(s): Death
• Patient Age: 62 YR