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

Model Number 1550400-15

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

Patient Problems Ischemia (1942); Stenosis (2263); Test Result (2695)

Event Date 08/05/2020

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

Patient (b)(6). It was reported that on (b)(6) 2019, the patient presented with angina and a severely calcified, 70% stenosed lesion within the proximal left anterior descending (lad) coronary artery. Pre-dilatation and an atherectomy were performed. Following, a 4. 0x15mm xience sierra stent (1550400-15, 8101641) was implanted without a device issue reported. The diameter stenosis was reduced to 0% with timi flow iii. On (b)(6) 2020, the patient was hospitalized for known in-stent restenosis which was being medically managed. A recent stress test revealed a small zone of reversibility in the inferior apex, suggesting mild ischemia. No additional information was provided regarding this issue.

• 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: 10479619
• MDR Text Key: 205287043
• Report Number: 2024168-2020-07281
• 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: health professional,study

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 11/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 10/21/2019
• Device Model Number: 1550400-15
• Device Catalogue Number: 1550400-15
• Device Lot Number: 8101641
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/28/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 09/01/2020 Patient Sequence Number: 1