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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 1120275-18
Device Problem Difficult or Delayed Positioning (1157)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/06/2017
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 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 similar incidents from this lot. The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely the device interacted with the mildly tortuous and heavily calcified lesion resulting in the reported difficulty to deploy. There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.
 
Event Description
It was reported that the procedure was to treat a 90% stenosed, mildly tortuous and heavily calcified de novo lesion in the mid left anterior descending artery. The patient presented with unstable angina. After pre-dilating the lesion several times, a 2. 75x18mm xience alpine was deployed; however, the stent did not appose well and there was clear dog boning due to calcium. An attempt was made to post- dilate the stent; however, the stent still did not appose to the vessel wall. The patient was sent for coronary artery bypass graft (cabg) surgery and is doing well. No additional information was provided.
 
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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 Key7155576
MDR Text Key96109829
Report Number2024168-2017-10161
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,distri
Reporter Occupation
Remedial Action Other
Type of Report Initial
Report Date 12/29/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/29/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/24/2020
Device Catalogue Number1120275-18
Device Lot Number7081041
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/08/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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

Patient Treatment Data
Date Received: 12/29/2017 Patient Sequence Number: 1
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