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U.S. Department of Health and Human Services

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

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AV-TEMECULA-CT XIENCE PROX EVEROLIMUS ELUTING RX CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM Back to Search Results
Catalog Number 1076400-12
Device Problems Leak/Splash (1354); Loose or Intermittent Connection (1371); Physical Property Issue (3008)
Patient Problem No Patient Involvement (2645)
Event Date 04/18/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The xience prox is currently not commercially available in the u. S. ; however, it is similar to a device sold in the u. S. Evaluation summary: a visual and functional inspection was performed on the returned device. The reported loose or intermittent connection was unable to be confirmed. The reported physical property issue/damages was able to be confirmed as there were cracks noted in the hub. Additionally when the device was pressurized, fluid leaked out of the cracks in the hub. As there was contrast in the inflation lumen consistent with preparation, the investigation determined the reported/noted difficulties appear to be related to circumstances of the procedure as it is likely that during preparation the inflation device was over torqued during connection to the hub resulting in the noted flash and cracks on the hub (reported physical property issue) thus resulting in the reported loose or intermittent connection. 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 other incidents from this lot. There is no indication of a product quality issue with respect to design, manufacture or labeling.
 
Event Description
It was reported that a 4. 0 x 12 mm xience pro x stent delivery system (sds) was unable to be connected to the indeflator because the port on the hub was damaged and could not be properly screwed onto the luer lock connector on the indeflator. The sds was not used in the patient and there was no patient involvement. A new device was used for the procedure. There were no adverse patient effects or clinically significant delay in the procedure reported. No additional information was provided. Returned device analysis indicated that the connection port of the hub was cracked and the pressure test confirmed a leak at the port.
 
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Brand NameXIENCE PROX EVEROLIMUS ELUTING RX 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 Key6635788
MDR Text Key77512484
Report Number2024168-2017-05003
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
P110019
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Remedial Action Other
Type of Report Initial
Report Date 06/12/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/12/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/08/2020
Device Catalogue Number1076400-12
Device Lot Number7013141
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/05/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/09/2017
Was Device Evaluated by Manufacturer? Yes
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

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