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U.S. Department of Health and Human Services

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

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AV-TEMECULA-CT XIENCE PRIME EVEROLIMUS ELUTING RX CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM Back to Search Results
Catalog Number 1011708-33
Device Problems Break (1069); Difficult To Position (1467); Unstable (1667); Physical Property Issue (3008)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/09/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. The customer reported the device was discarded. Investigation is not yet complete. A follow up report will be submitted with all relevant information. Xience pro x is currently not commercially available in the us; however, it is similar to a device sold in the us.
 
Event Description
It was reported that the procedure was to treat a mildly calcified lesion in a mildly tortuous mid left anterior descending coronary (lad) artery. A 2. 75x33mm xience pro x stent delivery system (sds) was advanced but did not cross due to the stent feeling heavy, not smooth, and unusual during advancement into an unspecified guiding catheter. It was reportedly unable to be advanced through the guiding catheter, resulting in fractured / broken stent struts at the front of the stent (but no separation of stent or struts) and the inability to visualize the marker as the stent had shifted on the balloon, covering a balloon marker. The sds was able to be withdrawn without resistance. No other device or procedure issues were noted. The patient was treated with a 2. 75x33 non-abbott stent. The patient experienced no untoward effects as a result of the failure to cross and there was no reported clinically significant delay in the procedure. No additional information was provided.
 
Manufacturer Narrative
(b)(4). Corrections to lot # and catalog #. 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 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.
 
Event Description
Subsequent to the initial filed medwatch report, additional information was received indicating that the complaint device is a 2. 75x33mm rx xience prime, not a 2. 75x33mm xience pro x, as initially reported. No additional information was provided.
 
Manufacturer Narrative
(b)(4). Evaluation summary: the device was returned for analysis. The reported shaft kink was able to be confirmed. The reported difficulty to position using a guiding catheter, the reported difficulty to position/visibility and the reported physical property issue/irregular texture were unable to be confirmed. 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 reported difficulty to position/visibility could not be confirmed. There is no indication of a product quality issue with respect to manufacture, design or labeling.
 
Event Description
Subsequent to the previously filed medwatch report, the abbott vascular returned goods lab received the 2. 75x33mm rx xience prime stent delivery system in the following condition: there were kinks in the proximal shaft, but there was no damage or break noted to the stent implant as reported. Additional information received confirmed that the correct device had been returned and that the physician meant only that the proximal shaft was kinked / bent and the marker was difficult to visualize. There was no issue with the stent implant itself; it was not damaged or broken and had not shifted. No additional information was provided.
 
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Brand NameXIENCE PRIME 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 Key6456799
MDR Text Key71898761
Report Number2024168-2017-02786
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,Followup,Followup
Report Date 05/11/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/04/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/13/2019
Device Catalogue Number1011708-33
Device Lot Number6070741
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/19/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/05/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/01/2016
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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