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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 1011709-38
Device Problems Material Separation (1562); Failure to Advance (2524)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/13/2021
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. The additional two devices referenced are filed under separate medwatch report numbers.
 
Event Description
It was reported that the procedure was to treat a heavily tortuous, heavily calcified right coronary artery (rca). A 3. 0x38mm xience prime stent delivery system (sds) was attempted to advance, but failed to cross. It was noted that the proximal shaft separated and the separated portion was simply withdrawn. A 3. 0x33mm xience prime was attempted to cross; however failed due to anatomy. A final attempt to cross was made with a 3. 0x18mm xience prime, but failed due to anatomy. Physician decided to end the procedure and keep the patient on medical management. There was no adverse patient effect and no clinically significant delay. 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 Key12259455
MDR Text Key264507929
Report Number2024168-2021-06697
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 Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/10/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/02/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number1011709-38
Device Lot Number0022541
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/23/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/08/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/03/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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