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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 1500350-23
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Intimal Dissection (1333); Cardiac Enzyme Elevation (1838); Prolapse (2475)
Event Date 05/15/2019
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 effects of intimal dissection and prolapse are listed in the xience sierra everolimus eluting coronary stent systems instructions for use as a known patient effects 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. The additional xience sierra stent mentioned is being filed under a separate medwatch report number.
 
Event Description
Patient id: (b)(6). It was reported that on (b)(6) 2019, the patient presented with a mid-left anterior descending (lad) 90% stenosed lesion, and a mid-right coronary artery (rca) 70% stenosed lesion. Following pre-dilatation, a 2. 5x38mm xience sierra stent (1500250-38, 9030141) was implanted in the mid lad. Post-stent placement, an intra-stent plaque, thrombus, and an edge dissection was observed. Additional post-dilatation performed. The end result was 0% residual stenosis with timi flow iii. Reportedly, there was no device malfunction. A 3. 5x23mm xience sierra stent (1500350-23, 9030441) was implanted in the mid rca. Post stent implantation, an intra-stent plaque protrusion and an edge dissection were observed. Additional post-dilatation was performed and a 3. 5x8mm xience sierra stent (1500350-08, 8112041) stent was implanted. Reportedly, there was no device malfunction the end results were 0% residual stenosis with timi flow iii. That same day post-procedure, elevated cardiac enzymes were observed and significantly elevated enzymes were observed (b)(6) 2019. Reportedly, the elevation was not serious, there was no associated serious injury, there was no device malfunction, and no treatment provided. The event resolved without sequela. 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 Key10359531
MDR Text Key203292889
Report Number2024168-2020-06453
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeFR
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 08/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/03/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/12/2022
Device Catalogue Number1500350-23
Device Lot Number9030441
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 Received07/16/2020
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 08/03/2020 Patient Sequence Number: 1
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