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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
Model Number 1550300-18
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Dyspnea (1816); Fatigue (1849); Ischemia (1942); Test Result (2695)
Event Date 09/29/2020
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 effects of ischemia and dyspnea are listed in the xience sierra, everolimus eluting coronary stent system instructions for use as known patient effects of coronary stenting procedures. A conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined; however, the reported treatments appear 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 of the device.
 
Event Description
Patient id: (b)(6). It was reported that on (b)(6) 2020, the patient presented with angina, severe calcification within the left anterior descending (lad) coronary artery, and a mid-lad, 80% stenosed lesion. Pre-dilatation was performed and a 3. 0x18mm xience sierra stent was implanted with acceptable results and no complications. Timi flow iii with 0% residual stenosis was observed. On (b)(6) 2020, the patient expressed experiencing fatigue and dyspnea during a follow-up visit. A stress test was performed and a large area of perfusion defect was observed in the lad area. Regarding the xience sierra stent, there was no restenosis and no device malfunction. As treatment, a new stent was placed within the proximal lad and medications were provided. The event did not require hospitalization. There was no device malfunction. 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 Key10705228
MDR Text Key212145934
Report Number2024168-2020-08720
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
P110019
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,study
Reporter Occupation
Type of Report Initial
Report Date 10/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/20/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/08/2021
Device Model Number1550300-18
Device Catalogue Number1550300-18
Device Lot Number0030241
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 Received10/02/2020
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 10/20/2020 Patient Sequence Number: 1
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