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

Catalog Number 1550300-23

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

Patient Problems Myocardial Infarction (1969); Weakness (2145); Stenosis (2263)

Event Date 06/27/2019

Event Type  Injury  

Manufacturer Narrative

Exemption number (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.It should be noted that the reported patient effects of stenosis and myocardial infarction are listed in the xience sierra, 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 reported treatment appears to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.

Event Description

Study patient id: (b)(6).It was reported that on (b)(6) 2018, a 3.0x23mm xience sierra stent was successfully implanted in the proximal right coronary artery (rca) lesion without procedure complications.On (b)(6) 2019, the patient was admitted to the hospital for weakness, a fall, acute kidney injury (aki), acute on chronic hypercapnic and hypoxic respiratory failure.Diagnostic labs were taken and imaging was performed.Elevated troponin was observed and a myocardial infarction (mi) was diagnosed.Per imaging, the proximal rca xience sierra stent had 90% in-stent restenosis (isr).A lexiscan stress test was performed, showing a reversible defect.The patient continued previously prescribed medications and diuretics were held.Per physician, the kidney injury and respiratory failure were a worsening of pre-existing conditions.Per physician, the events were unrelated to the device.On (b)(6) 2019, a diagnostic percutaneous procedure was performed.Upon further evaluation, it was decided to not perform coronary stenting as there was significant 2-vessel coronary artery disease.The proximal left anterior artery (lad) was 80% stenosed, not amenable to stenting, and there was 90% proximal rca isr.The patient has been referred to cardiothoracic surgery for possible coronary artery bypass graft (cabg) placement.There was no device malfunction.No additional information was provided regarding this issue.

• Brand Name: XIENCE SIERRA
• Type of Device: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005718570 (P099); cashel road; clonmel tipperary ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 9135531
• MDR Text Key: 162545118
• Report Number: 2024168-2019-12210
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648227271
• UDI-Public: 08717648227271
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/26/2019
• Device Catalogue Number: 1550300-23
• Device Lot Number: 8041741
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/11/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2018
• 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; Required Intervention; Disability
• Patient Age: 79 YR
• Patient Weight: 128