MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE DRUG ELUTING CORONARY STENT; DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

Catalog Number 1009530-28

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

Patient Problems Arrhythmia (1721); Death (1802); Ventricular Tachycardia (2132)

Event Date 02/05/2020

Event Type  Death  

Manufacturer Narrative

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 information reviewed, there is no indication of a product quality issue.The reported patient effects of death and arrhythmia are listed in the xience v everolimus eluting coronary stent system, instructions for use as known patient effects of coronary stenting procedures.A conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined; however, the subsequent treatments appear to be related to the operational context of the procedure.Per the physician, the patient's death is unrelated to the xience v stent.There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.

Event Description

It was reported that the procedure was to treat a mildly tortuous, and mildly calcified de novo lesion in the right coronary artery.The patient presented with extensive myocardial infarction with inferior-wall myocardial infarction, cardiogenic shock, and very low blood pressure.Following pre-dilatation with a 2.0x12mm traveler balloon dilatation catheter (bdc), a 3.5x28mm xience v stent was implanted.Post-dilatation was performed with 3.5x12mm nc traveler bdc.The angioplasty was performed at 9:30pm.Post angioplasty the patient was shifted to the intensive care unit (icu).While in the icu, at around 10 am the next morning, the patient had ventricular tachycardia (vt) and then went to complete heart block.When the vt occurred, cardiopulmonary resuscitation was given to the patient; however, as the patient had complete heart block the patient could not be saved and expired.In the physicians opinion, the 3.5x28mm xience v stent did not cause or contribute to the death.No additional information was provided.

Manufacturer Narrative

Nana.

Event Description

The following additional information was received.There was a 90% blockage in mid right coronary artery.Anticoagulants given after intervention was clopidogrel and aspirin.No autopsy performed.No additional information was provided.

• Brand Name: XIENCE DRUG ELUTING CORONARY STENT
• Type of Device: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9764516
• MDR Text Key: 181181657
• Report Number: 2024168-2020-01843
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• PMA/PMN Number: P070015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 08/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/04/2021
• Device Catalogue Number: 1009530-28
• Device Lot Number: 9073141
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death