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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 1076275-18
Device Problems Detachment Of Device Component (1104); Kinked (1339); Failure to Advance (2524); Physical Property Issue (3008)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/23/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. Evaluation summary: the device was returned for analysis. The reported shaft kink was able to be confirmed and a hypotube shaft separation was noted. The reported physical property issue (fragility) was unable to be confirmed. The reported failure to advance was unable to be replicated in a testing environment as it was based on operational circumstances. 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 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. The xience prox device is currently not commercially available in the u. S; however, it is similar to a device sold in the us.
 
Event Description
It was reported that the procedure was to treat a moderately calcified, de novo lesion in the moderately tortuous mid left anterior descending (lad) coronary artery. While advancing a 2. 75 x 18 mm rx xience pro x drug-eluting stent (des) system into the mid lad, the rx xience pro x failed to cross the calcified lesion due to patient anatomy and the proximal shaft kinked. No unusual force was applied. The device was withdrawn without difficulty. There was no visible damage to the stent itself. Reportedly, this rx xience pro x delivery system seems fragile. There were no adverse patient effects and no occurrence of a clinically significant delay. The target lesion was treated with another unspecified stent. No additional information was requested. The 2. 75 x 18 mm rx xience pro x drug-eluting stent (des) system was received by the abbott vascular returned goods lab with a hypotube separation. Additional information received indicated that the site was not aware of the hypotube separation.
 
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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 Key6836646
MDR Text Key85118255
Report Number2024168-2017-07197
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeID
PMA/PMN Number
P110019
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Remedial Action Other
Type of Report Initial
Report Date 08/31/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/31/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/13/2020
Device Catalogue Number1076275-18
Device Lot Number7030142
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/07/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/17/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2017
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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