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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AV-TEMECULA-CT XIENCE PRO 48 EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM

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AV-TEMECULA-CT XIENCE PRO 48 EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM Back to Search Results
Catalog Number 1017250-48
Device Problems Break (1069); Physical Resistance (2578); Physical Property Issue (3008)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/28/2017
Event Type  malfunction  
Manufacturer Narrative
Internal file number - (b)(4). Evaluation summary: the device was returned for analysis. The reported irregular appearance was able to be confirmed and the reported shaft break was noted to be a shaft kink and multiple hypotube bends. The reported physical resistance was unable to be replicated in a testing environment as it was based on operational circumstances. The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that as the stent delivery system was advanced resistance was met with the heavily calcified anatomy resulting in the reported physical resistance. Manipulation of the device resulted in the reported irregular appearance and the noted shaft kink and bends. 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 did not indicate a lot specific quality issue. There is no indication of a product quality issue with respect to manufacture, design or labeling.
 
Manufacturer Narrative
(b)(4). The device is expected to be returned for evaluation. It has not yet been received. A follow up report will be submitted with all relevant information. The xience pro 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 long lesion located in the heavily calcified and narrow distal left anterior descending (lad) artery. Rotablation of the lesion was performed followed by predilatation with a 2. 5 x 20 mm nc trek balloon catheter. The 2. 5 x 48 mm xience pro 48 stent delivery system was advanced; however, a lot of resistance was felt due to the heavily calcified lesion. It was also stated that during advancement the proximal shaft completely deformed and broke; however, the stent delivery system was able to reach the lesion and the stent was able to be deployed successfully in the distal lad. Another non-abbott stent was deployed successfully overlapping the xience pro 48 treating the proximal part of the lad. No adverse patient effects were reported. There was a delay in the procedure reported; however, it was not clinically significant for the patient. No additional information was provided.
 
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Brand NameXIENCE PRO 48 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 Key6505133
MDR Text Key195187804
Report Number2024168-2017-03396
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeUK
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 08/29/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/19/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/05/2019
Device Catalogue Number1017250-48
Device Lot Number6062541
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/16/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/23/2017
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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