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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 1550350-23
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Intimal Dissection (1333); Angina (1710); Myocardial Infarction (1969); Occlusion (1984); Thrombosis (2100); Stenosis (2263); Prolapse (2475)
Event Date 06/23/2020
Event Type  Injury  
Manufacturer Narrative
The stent remains in patient and will not be returned for evaluation. The investigation is not yet complete. A follow-up report will be submitted with all additional relevant information.
 
Event Description
Patient id: (b)(6). It was reported that on (b)(6) 2020, the patient presented with a recent non-st elevated myocardial infarction (nstemi), elevated cardiac enzymes, and a proximal circumflex (cx), 95% stenosed lesion. A percutaneous coronary intervention was performed. Pre-dilatation was performed on the cx lesion and a 3. 5x23mm xience sierra stent (1550350-23, 9120941) stent was implanted with acceptable results. Post-implantation, a proximal edge dissection was observed. As treatment, a 2. 5x38mm xience sierra stent (1550250-38, 90100341) and a 4. 0x8mm xience sierra stent (1550400-08, 0051241) were implanted. Post-procedure imaging was performed with intra-stent plaque protrusion or thrombus, and dissection, unknown if this was the same previous dissection, were observed. The stent was not specified in this case. On (b)(6) 2020, the patient was admitted to the hospital with chest pain. Elevated cardiac enzymes were observed and a new myocardial infarction (mi) was diagnosed. As treatment, another pci was performed within the 50% occluded, proximal cx. The event resolved without sequela. Reportedly, 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 Key10690943
MDR Text Key211916956
Report Number2024168-2020-08661
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,Followup
Report Date 11/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/16/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date12/12/2020
Device Model Number1550350-23
Device Catalogue Number1550350-23
Device Lot Number9120941
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 Received11/04/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/13/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/16/2020 Patient Sequence Number: 1
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