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U.S. Department of Health and Human Services

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

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ABBOTT VASCULAR XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT DELIVERY SYSTEM Back to Search Results
Catalog Number 1011707-33
Device Problems Material Separation (1562); Failure to Advance (2524)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/22/2021
Event Type  malfunction  
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 as it is likely the device interacted with the heavily calcified lesion during advancement causing the reported failure to advance. Continued handling and manipulation of the device during attempted advancement likely caused the reported shaft separation. There is no indication of a product quality issue with respect to manufacture, design or labeling. The other stent delivery system referenced is filed under separate medwatch report number.
 
Event Description
It was reported that the procedure was to treat two heavily calcified lesions, one in the left circumflex (lcx) and the other in the left anterior descending (lad) coronary artery. Wires and balloons experienced difficulties accessing the lesions, but a few crossed and the lesions were able to be pre-dilated. A 2. 25x28mm xience prime drug eluting stent (des) was then advanced toward the lcx, and while attempting to push through the heavy calcification, the shaft of the des broke and separated into two pieces. The device was easily removed. The lesion was dilated again, but another des failed to cross the lesion. The lad was then pre-dilated lesion and a 2. 5x33mm xience prime des was advanced but the anatomy was too calcified to cross and the shaft separated into 2 pieces. The device was easily removed. The lesion was dilated again and the patient was referred for coronary artery bypass graft surgery. No additional information was provided.
 
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Brand NameXIENCE PRIME LL 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 Key12155874
MDR Text Key261248968
Report Number2024168-2021-05991
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 07/12/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/12/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number1011707-33
Device Lot Number0061841
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 Received06/24/2021
Is This a Reprocessed and Reused Single-Use Device? No

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