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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 1011709-28
Device Problems Difficult to Remove (1528); Material Separation (1562); Failure to Advance (2524); Device Dislodged or Dislocated (2923)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/19/2023
Event Type  malfunction  
Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
 
Event Description
It was reported that the procedure was to treat the tibial artery.The 3.0x28 mm xience prime stent delivery system (sds) was being advanced when it was caught on calcium in the distal superficial artery/popliteal artery.The device was removed; however, there was resistance with the calcium during removal and the stent dislodged but remained on the delivery system.The stent was removed from the patient on the delivery system without any issues.A drug coated balloon was used to complete the procedure.There were no adverse patient effects and there was no clinically significant delay in the procedure.No additional information was provided.
 
Event Description
It was reported that the procedure was to treat the tibial artery.The 3.0x28 mm xience prime stent delivery system (sds) was being advanced when it was caught on calcium in the distal superficial artery/popliteal artery.The device was removed; however, there was resistance with the calcium during removal and the stent dislodged but remained on the delivery system.The stent was removed from the patient on the delivery system without any issues.A drug coated balloon was used to complete the procedure.There were no adverse patient effects and there was no clinically significant delay in the procedure.Subsequent to the initially filed report, it was reported that the account mistook the separated outer member and skive to be a dislodged stent.No additional information was provided.
 
Manufacturer Narrative
The device was returned for analysis.The reported material separation was confirmed.The reported failure to advance and difficulty to remove 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.There is no indication of a product quality issue with respect to manufacture, design or labeling.D4 - serial # updated from na to 78582.H6 - medical device problem code 2923 was removed and device code 1562 was added.
 
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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
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 Key17684725
MDR Text Key322660935
Report Number2024168-2023-09622
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeAS
PMA/PMN Number
P110019
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 10/25/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/05/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number1011709-28
Device Lot Number3022141
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/04/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/14/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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