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

Catalog Number 1550225-15

Device Problems Expiration Date Error (2528); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Syncope (1610); Dyspnea (1816); Cardiac Enzyme Elevation (1838); Fatigue (1849); Low Blood Pressure/ Hypotension (1914); Myocardial Infarction (1969); Thrombosis (2100); Stenosis (2263); Diaphoresis (2452)

Event Date 08/19/2019

Event Type  Injury  

Manufacturer Narrative

The stent remains in the patient. Investigation is not yet complete. A follow up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was performed on (b)(6) 2020, to treat a lesion in the left main coronary artery. The patient had a xience sierra stent was implanted successfully with no tissues. However, the patient was re-hospitalized on (b)(6) 2020 for fatigue, hypotension, and dyspnea. Medication was administered. Elevated troponin and a myocardial infarction (mi) were diagnosed. A heparin was administered. Angiography revealed in-stent stenosis was observed in the implanted stent. An unspecified stent was implanted as treatment within the xience sierra stent implant. The patient is stable. No additional information was provided.

• Brand Name: XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• 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: 9829734
• MDR Text Key: 183294312
• Report Number: 2024168-2020-02399
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 1550225-15
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/10/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-2370-2020

Patient Treatment Data

Date Received: 03/13/2020 Patient Sequence Number: 1