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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 1125300-18
Device Problems Leak / Splash; Improper or Incorrect Procedure or Method; Physical Resistance
Event Date 09/24/2015
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. The device was received. Investigation is not yet complete. A follow up report will be submitted with all relevant information.

 
Event Description

It was reported that the procedure was to treat a lesion in the right coronary artery, with moderate tortuosity and heavy calcification. Pre-dilatation was performed. A 3. 0x18mm xience alpine stent delivery system (sds) was prepped for use and air aspiration was performed outside the patient anatomy. No issues were noted at that time. The 3. 0x18mm xience alpine sds was advanced but failed to cross the lesion due to resistance with the anatomy. Several attempts were made to cross the lesion. Double wire technique was used and the 3. 0x18mm xience alpine sds was removed for further pre-dilatation. The 3. 0x18mm xience alpine sds was re-inserted and the 3. 0x18mm xience alpine sds finally crossed the lesion. Negative was pulled before the 3. 0x18mm xience alpine sds was pressurized, and blood was observed coming into the indeflator. Thus, the 3. 0x18mm xience alpine sds was removed from the patient anatomy. The procedure was completed with a new non-abbott sds. No adverse patient effect was reported and no clinically significant delay in the procedure was reported. No additional information was provided.

 
Manufacturer Narrative

(b)(4). Unique device identifier (udi): (b)(4). Evaluation summary: the device was returned for analysis. The reported leak was able to be confirmed. The reported physical resistance was unable to be replicated in a testing environment as it was based on operational circumstances. Based on a visual, dimensional and functional inspection of the returned device, there is no indication of a product quality issue with respect to manufacture, design or labeling. Based on the information provided, the reported difficulties appear to be related to circumstances of the procedure and not a product quality issue with respect to manufacture, design or labeling. 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. It should be noted that the xience alpine everolimus eluting coronary stent system electronic instructions for use states: an unexpanded stent may be retracted into the guiding catheter one time only. An unexpanded stent should not be reintroduced into the artery once it has been pulled back into the guiding catheter. Subsequent movement in and out through the distal end of the guiding catheter should not be performed as the stent may be damaged or/ and dislodged from the balloon when retracting the undeployed stent back into the guiding catheter. Based on the information reviewed, there is no evidence to indicate the presence a potential quality issue with respect to manufacture, design or labeling.

 
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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 Key5154930
Report Number2024168-2015-06103
Device Sequence Number1
Product CodeNIQ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation HEALTH PROFESSIONAL
Remedial Action Other
Type of Report Initial,Followup
Report Date 11/05/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/15/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date12/16/2017
Device Catalogue Number1125300-18
Device LOT Number4120941
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer10/12/2015
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/23/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/01/2014
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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