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

Catalog Number 1500300-28

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

Patient Problems Angina (1710); Non specific EKG/ECG Changes (1817); Stenosis (2263); Test Result (2695)

Event Date 12/22/2020

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.It should be noted that the reported patient effect(s) of stenosis and angina are listed in the xience sierra everolimus eluting coronary stent systems instructions for use as a known patient effect(s) of coronary procedures.A conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

Patient id: (b)(6).It was reported that on (b)(6) 2019, the patient presented with a mid-right coronary artery (rca), 80% stenosed lesion and a percutaneous coronary intervention (pci) was performed.Pre-dilatation was performed on the mid rca and a 2.5x23mm (1500250-23, 9080641) and 3.0x28mm (1500300-28, 9081641) xience sierra stents were implanted with acceptable results.On (b)(6) 2020, the patient had presented with angina and a positive stress test with st depression in v4-v6 leads.On (b)(6) 2021, a diagnostic coronary angiogram was performed with moderate (40%) stenosis just before the previously implanted, mid rca 3.0x28mm xience sierra stent.The mid rca 2.5x23mm xience sierra stent remained patent.Additional hospitalization was not required, and no treatment was provided.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: 11324240
• MDR Text Key: 234325710
• Report Number: 2024168-2021-01170
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: SP
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/22/2022
• Device Catalogue Number: 1500300-28
• Device Lot Number: 9081641
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 67 YR
• Patient Weight: 68