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

Model Number 1550350-18

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

Patient Problem Heart Failure/Congestive Heart Failure (4446)

Event Date 02/11/2021

Event Type  Injury  

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.The reported patient effect of cardiac failure (heart failure) is listed in the xience sierra everolimus eluting coronary stent systems instructions for use (ifu) as a known patient effect of coronary procedures.A conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.However, the treatments 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.Na.

Event Description

It was reported that on (b)(6) 2021 the patient presented with non-st elevated myocardial infarction (nstemi); therefore, the 3.50x18mm xience sierra was implanted.On (b)(6) 2021 the patient was re-admitted with heart failure.It is unknown what treatment was performed and the final patient outcome is unknown.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: 11897658
• MDR Text Key: 253144008
• Report Number: 2024168-2021-04467
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648227424
• UDI-Public: 08717648227424
• 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: other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/22/2022
• Device Model Number: 1550350-18
• Device Catalogue Number: 1550350-18
• Device Lot Number: 0101541
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 70 YR
• Patient Weight: 122