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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 1076400-33
Device Problems Break (1069); Detachment Of Device Component (1104); Positioning Failure (1158); Difficult to Remove (1528); Device Dislodged or Dislocated (2923)
Patient Problem Vessel Or Plaque, Device Embedded In (1204)
Event Date 12/09/2016
Event Type  Injury  
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. The xience prox is currently not commercially available in the u. S. ; however, it is similar to a device sold in the u. S.
 
Event Description
It was reported that the procedure was to treat a de novo lesion located in the mid circumflex artery that was non-tortuous and non- calcified. After pre-dilatation with a non-abbott balloon, the xience prox 4. 0 x 33 mm stent delivery system (sds) was positioned. When the sds was attempted to be inflated, the shaft broke and balloon would only inflate to 4 atmospheres before the pressure fell. When the sds was removed, slight resistance was met with the guide catheter and the shaft separated 30 cm proximal to the distal end. The partially expanded stent slid off the balloon and remained in the vessel. An attempt was made to snare the broken shaft: however, it was not successful. A balloon was then inserted to the end of the guide catheter and the entire sds was removed from the anatomy. Two xience prox stents (4. 0 x 18 mm and 3. 5 x 23 mm) were used to compress the dislodged stent to the vessel wall. There was no adverse patient sequela. There was no clinically significant delay reported. No additional information was provided.
 
Manufacturer Narrative
(b)(4). Evaluation summary: the device was returned for analysis. The reported break and detachment were able to be confirmed. The reported stent dislodgement was able to be confirmed. The reported failure to deploy and the reported difficult to remove were unable to be replicated in a testing environment as they were based on operational circumstances. The investigation determined the reported difficulties appear to be related to circumstances of the procedure. 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 manufacture, design or labeling.
 
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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 Key6227072
MDR Text Key64017505
Report Number2024168-2017-00127
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodePL
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,Followup
Report Date 02/02/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/05/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/10/2019
Device Catalogue Number1076400-33
Device Lot Number6030841
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer01/03/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/26/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2016
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: 01/05/2017 Patient Sequence Number: 1
Treatment
SHEATH: EBU 4.0 6F
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