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U.S. Department of Health and Human Services

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

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ABBOTT VASCULAR XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT DELIVERY SYSTEM Back to Search Results
Catalog Number 1009530-18
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Intimal Dissection (1333)
Event Date 12/28/2020
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. A conclusive cause for the reported patient effects, 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. The reported patient effect of dissection is listed in the xience v everolimus eluting coronary stent system instructions for use as a known patient effect of coronary stenting procedures. There is no indication of a product quality issue with respect to manufacture, design or labeling.
 
Event Description
It was reported that this was a procedure to treat a de novo lesion in the right coronary artery with moderate calcification and heavy tortuosity. A 3. 5x18 mm xience v stent was implanted when a distal edge dissection was observed. The dissection was covered with a 3. 5 x 12 mm xience stent. There was no clinically significant delay in the procedure. No additional information was provided.
 
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Brand NameXIENCE V 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 Key11163500
MDR Text Key226573377
Report Number2024168-2021-00388
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeIN
PMA/PMN Number
P070015
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 01/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/13/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/25/2021
Device Catalogue Number1009530-18
Device Lot Number9041941
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 Received12/29/2020
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 01/13/2021 Patient Sequence Number: 1
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