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U.S. Department of Health and Human Services

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

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AV-TEMECULA-CT XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM Back to Search Results
Catalog Number 1011709-23
Device Problems Product Quality Problem (1506); Difficult to Remove (1528); Material Deformation (2976); Physical Property Issue (3008)
Patient Problem No Patient Involvement (2645)
Event Date 03/20/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Internal file number - (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 mildly tortuous, moderately calcified, and de novo lesion located in the mid left anterior descending artery. A 3. 0 x 23 mm xience prime stent was removed from the box and there was slight resistance during uncoiling and when removing the protective sheath. There was a bulge on the sheath, and it was noticed the proximal and distal edges of the stent were flared, and the balloon was partially inflated. This stent was not used in the patient. An attempt was made to use a new 3. 0 x 23 mm xience prime stent, but it could not cross due to the anatomy. The procedure was successfully completed with a 3. 0 x 18mm xience prime stent. There were no adverse patient effects and no reported clinically significant delay in the procedure or therapy. No additional information was provided.
 
Manufacturer Narrative
(b)(4). The device was returned for analysis. The reported product quality issue (partially inflated) was confirmed and the reported flared stent was not confirmed. The reported difficulty to remove (sheath) and physical property issue (bulged sheath) could not be confirmed since the sheath was not returned for analysis. Additionally, the reported difficulty to remove (hoop dispenser) could not be confirmed due to device condition. 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 similar incidents from this lot. The investigation was unable to determine a conclusive cause for the reported issues. There is no indication of a product quality issue with respect to manufacture, design or labeling.
 
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Brand NameXIENCE PRIME 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 Key7544819
MDR Text Key109496916
Report Number2024168-2018-03924
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeIN
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 06/14/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/25/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/21/2020
Device Catalogue Number1011709-23
Device Lot Number7081641
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer04/25/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/31/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/01/2017
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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