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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AV-TEMECULA-CT XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT SYSTEM

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AV-TEMECULA-CT XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT SYSTEM Back to Search Results
Catalog Number 1125350-12
Device Problems Difficult to Remove (1528); Failure to Advance (2524); Device Damaged by Another Device (2915); Device Dislodged or Dislocated (2923)
Patient Problem Vessel Or Plaque, Device Embedded In (1204)
Event Date 12/07/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4).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 did not indicate a lot specific quality issue.The investigation determined the reported difficulties and treatment appear to be related to circumstances of the procedure as it is likely the device interacted with the previously deployed stent causing the reported failure to advance and subsequently the reported difficulty to remove.Resistance was felt during removal of the device likely due to the reported interaction with the previously deployed stent causing the reported stent dislodgement and damage to the previously implanted stent.There is no indication of a product quality issue with respect to manufacture, design or labeling.
 
Event Description
It was reported that the procedure was performed to treat a lesion in the distal left main (lm) coronary artery with mild calcification and restenosis.Following the deployment of a 4.0 x 12 mm non-abbott stent in the ostium of the lm, a 3.50 x 12mm xience alpine stent delivery system (sds) was advanced; however could not cross into the ostium of the circumflex artery due to interaction with the previously deployed stent.An attempt to withdraw the sds into the guide catheter was made, but the stent of the sds was stuck and dislodged.The dislodged stent was located outside the lm close to the aorta and proximal to the deployed stent.The deployed non-abbott stent was noted to be stretched.An additional non-abbott stent was deployed to secure both the dislodged and deployed stents and treat the target lesion.The patient was reported to be stable with good blood flow.No additional information was provided.
 
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Brand Name
XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM
Type of Device
DRUG ELUTING CORONARY STENT SYSTEM
Manufacturer (Section D)
AV-TEMECULA-CT
abbott vascular
26531 ynez road
temecula CA 92591 4628
Manufacturer (Section G)
CLONMEL, IRELAND REG# 9616693
abbott vascular
26531 ynez road
temecula CA 92591 4628
Manufacturer Contact
connie speck
abbott vascular
26531 ynez road
temecula, CA 92591-4628
9519143996
MDR Report Key8166605
MDR Text Key130459580
Report Number2024168-2018-09727
Device Sequence Number1
Product Code NIQ
UDI-Device Identifier08717648199516
UDI-Public08717648199516
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P110019
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Remedial Action Other
Type of Report Initial
Report Date 12/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/04/2021
Device Catalogue Number1125350-12
Device Lot Number8022041
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/07/2018
Initial Date FDA Received12/14/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/01/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age67 YR
Patient Weight70
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