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U.S. Department of Health and Human Services

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

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ABBOTT VASCULAR XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT DELIVERY SYSTEM Back to Search Results
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.
 
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Brand NameXIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM
Type of DeviceDRUG 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 Key11324240
MDR Text Key234325710
Report Number2024168-2021-01170
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeSP
PMA/PMN Number
P110019
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,s
Reporter Occupation
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 Received02/12/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number1500300-28
Device Lot Number9081641
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 Received01/22/2021
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 02/12/2021 Patient Sequence Number: 1
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