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U.S. Department of Health and Human Services

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

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ABBOTT VASCULAR XIENCE DRUG ELUTING CORONARY STENT DRUG ELUTING CORONARY STENT DELIVERY SYSTEM Back to Search Results
Catalog Number 1009532-18E
Device Problems Failure to Advance (2524); Device Dislodged or Dislocated (2923)
Patient Problem Vessel Or Plaque, Device Embedded In (1204)
Event Date 07/15/2020
Event Type  Injury  
Manufacturer Narrative
The device was not returned for analysis. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event. Additionally, a review of the complaint history identified no other incidents from this lot. The investigation determined the reported difficulties appear to be related to circumstances 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 performed to treat a moderately calcified, mildly tortuous left circumflex lesion that was 95% stenosed. After pre-dilatation, the 2. 25x18mm rx everlink stent delivery system (sds) failed to cross the lesion due to the anatomy or stent (it was not specified by the physician). The stent dislodged while withdrawing the sds. An attempt was made to snare the stent but was unsuccessful. Therefore, the stent was embedded in healthy tissue. A clinically significant delay was reported. There was no adverse patient sequela reported. No additional information was provided.
 
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Brand NameXIENCE DRUG ELUTING CORONARY STENT
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 Key10335168
MDR Text Key200698411
Report Number2024168-2020-06260
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeCH
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 07/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/28/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/22/2022
Device Catalogue Number1009532-18E
Device Lot Number0031241
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: 07/28/2020 Patient Sequence Number: 1
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