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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 1125400-15
Device Problems Inflation Problem (1310); Device Dislodged or Dislocated (2923)
Patient Problem Vessel Or Plaque, Device Embedded In (1204)
Event Date 05/10/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4). Internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information. The device is expected to be returned for evaluation. It has not yet been received. A follow up report will be submitted with all relevant information.
 
Event Description
It was reported that the procedure was to treat a lesion located in the proximal right coronary artery (rca) with mild calcification and no tortuosity. Pre-dilatation was performed using a non-abbott balloon dilatation catheter (bdc). A 4. 0 x 12 mm xience alpine rx stent delivery system (sds) was advanced to the lesion and it crossed successfully; however, the balloon would not inflate. When the sds was removed from the anatomy, the stent completely dislodged from the balloon and remained in the proximal rca. Another xience alpine was advanced to the lesion and deployed to crush the dislodged stent against the vessel wall at the lesion. The patient was stated to be doing fine. No additional information was provided.
 
Manufacturer Narrative
(b)(4). Correction: case description. Correction: - it was initially reported that the device would be returned for analysis. Subsequent information revealed that the device was discarded and is not available for evaluation. Correction: (b)(4) was removed. The device was not returned for analysis. The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that as the sds was advanced resistance was met with the mildly calcified anatomy resulting in the reported failure to advance. Interaction with the anatomy and/or interaction with other devices resulted in the reported stent dislodgement. 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. There is no indication of a product quality issue with respect to manufacture, design or labeling.
 
Event Description
The following additional information was received: it was a 4. 0 x 15 mm xience alpine rx stent delivery system (sds) used in the procedure, not a 4. 0 x 12 mm as previously reported. Additionally, the balloon was never inflated. The sds was advanced to the lesion, but would not cross it due to the calcification. During removal of the sds, the stent completely dislodged from the balloon. A balloon was used in attempt to deploy the stent in the artery, but it was unsuccessful. An attempt to snare the stent was also unsuccessful. Another xience alpine stent was finally used to crush the stent against the vessel wall at the lesion. The final patient outcome was good. No additional information was provided.
 
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Brand NameXIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM
Type of DeviceDRUG 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 Key6606434
MDR Text Key76480284
Report Number2024168-2017-04702
Device Sequence Number1
Product Code NIQ
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
Remedial Action Other
Type of Report Initial,Followup
Report Date 06/08/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/01/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/13/2020
Device Catalogue Number1125400-15
Device Lot Number7020241
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/07/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/01/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/01/2017 Patient Sequence Number: 1
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