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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 05/09/2022
Event Type  malfunction  
Event Description
It was reported that the procedure was to treat a de novo, heavily calcified and heavily tortuous vessel in the mid right coronary artery (rca). The 3. 0x38mm xience prime stent delivery system (sds) could not cross the lesion due to the anatomy and the proximal shaft separated. Another 3. 0x38mm xience prime sds was attempted to be used but could not cross the lesion due to the anatomy and the proximal shaft separated. A 2. 75x38mm xience prime sds, smaller diameter, was attempted to be used but could not cross the lesion due to the anatomy and the proximal shaft separated. A 2. 75x23mm, small size with small diameter, also failed to cross the lesion due to the anatomy and the proximal shaft separated. There was no resistance for all the sds and were simply withdrawn from the anatomy. The physician abandoned the case, however, the patient is fine and kept on medical management. There was no adverse patient effect and there was no clinically significant delay in the procedure. No additional information was provided.
 
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 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 and subsequent shaft separation. There is no indication of a product quality issue with respect to manufacture, design or labeling. The three additional xience prime stent delivery systems (sds) are being filed under separate medwatch report numbers.
 
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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 Key14522853
MDR Text Key292817846
Report Number2024168-2022-05703
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
Report Date 05/27/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/27/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number1011709-38
Device Lot Number1111742
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/10/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/22/2021
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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