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

Catalog Number 1017275-28

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

Patient Problems Bradycardia (1751); Cardiac Arrest (1762); Death (1802); Low Blood Pressure/ Hypotension (1914); Respiratory Distress (2045)

Event Date 10/15/2016

Event Type  Death  

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.The reported patient effects of bradycardia, death, and hypotension are listed in the xience pro everolimus eluting coronary stent system expanded indications electronic instructions for use as known patient effects of coronary stenting procedures.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.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.The xience pro is currently not commercially available in the u.S; however, it is similar to a device sold in the u.S.

Event Description

It was reported that the patient presented to the hospital with acute myocardial infarction (ami).The procedure was to treat a de novo lesion located in the proximal obtuse marginal that was mildly tortuous, moderately calcified and 100% stenosed.A xience pro 2.75 x 28 mm stent was deployed followed by post dilatation with an non- compliant balloon.Timi 3 flow was achieved and the patient was transferred to the intensive care unit (icu).The patient was taking aspirin and clopidogrel.Heparin and integrilin were the anticoagulants administered during treatment.Sometime after, the patient suffered sudden onset of hypotension with bradycardia that was treated with inotropes and iv fluids.The patient was put on a ventilator but expired early morning the next day on (b)(6) 2016.The patient's death was confirmed to be the result of medical complications due to the ami.Cause of death was cardiac arrest.No autopsy was performed.No additional information was provided.

• Brand Name: XIENCE PRO EVEROLIMUS ELUTING RX 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: 6070715
• MDR Text Key: 58913796
• Report Number: 2024168-2016-07460
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648181764
• UDI-Public: (01)08717648181764(17)180306(10)6022641
• 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: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 11/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/06/2018
• Device Catalogue Number: 1017275-28
• Device Lot Number: 6022641
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2016
• 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): Death
• Patient Age: 63 YR