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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 1011709-23
Device Problems Material Separation (1562); Failure to Advance (2524)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/05/2021
Event Type  malfunction  
Manufacturer Narrative
The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all additional relevant information.
 
Event Description
It was reported that the procedure was to treat the heavily calcified, heavily tortuous left anterior descending (lad) coronary artery.The 3.0x23 mm xience prime stent delivery system (sds) was unable to cross the lesion due to the anatomy and the proximal shaft of the sds separated.The separated portion was simply withdrawn.There were no adverse patient effects.The patient was treated with medical management.There was no reported clinically significant delay in the procedure.No additional information was provided.
 
Manufacturer Narrative
The device was returned for analysis.The reported material separation was confirmed.The reported failure to advance could not be replicated in a testing environment as it was related to operational context of the procedure.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 similar 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 and heavily tortuous artery causing the reported failure to advance.Continued handling and/or manipulation of the device during the attempt to cross the lesion likely caused the reported material separation.There is no indication of a product quality issue with respect to manufacture, design or labeling.
 
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Brand Name
XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM
Type of Device
DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
Manufacturer (Section D)
ABBOTT VASCULAR
26531 ynez rd.
temecula CA 92591 4628
MDR Report Key12343232
MDR Text Key267294303
Report Number2024168-2021-07311
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
PMA/PMN Number
P110019
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 10/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/25/2023
Device Catalogue Number1011709-23
Device Lot Number0061741
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/14/2021
Initial Date Manufacturer Received 08/05/2021
Initial Date FDA Received08/19/2021
Supplement Dates Manufacturer Received10/21/2021
Supplement Dates FDA Received10/25/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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