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U.S. Department of Health and Human Services

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

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ABBOTT VASCULAR XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT DELIVERY SYSTEM Back to Search Results
Catalog Number 1011709-28
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Intimal Dissection (1333)
Event Date 12/21/2020
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. The reported patient effect of dissection is listed in the xience prime, everolimus eluting coronary stent system instructions for use as a known patient effect 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 treatment appears 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.
 
Event Description
It was reported that the procedure was to treat the moderately tortuous, mildly calcified lesion in the mid left anterior descending (lad) coronary artery. The 3. 0x28 mm xience prime stent was implanted and a proximal edge dissection was noted. A 2. 75x12mm xience v stent was used to cover the dissection. There were no reported adverse patient sequela and there was no reported clinically significant delay in the procedure. No additional information was provided.
 
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Brand NameXIENCE PRIME 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 Key11133660
MDR Text Key225597183
Report Number2024168-2021-00227
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeIN
PMA/PMN Number
P110019
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial
Report Date 01/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/07/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number1011709-28
Device Lot Number0022141
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 Received12/22/2020
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 01/07/2021 Patient Sequence Number: 1
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