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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 1120350-23
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Atrial Fibrillation (1729); Myocardial Infarction (1969); Occlusion (1984); Heart Failure (2206)
Event Date 10/10/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. Concomitant medical products: scaffold: 3. 0 x 28 mm absorb gt1, guide catheter: 6f xb 3. 0. The device was not returned for evaluation. A review of the lot history record and complaint history of the reported device could not be conducted because the lot number was not provided. A conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined. However, atrial arrhythmias, myocardial infarction, occlusion, and congestive heart failure are listed in the instructions for use as known patient effects of coronary stenting procedures. There is no indication of a product quality issue with respect to manufacture, design or labeling. The 3. 0 x 28 mm absorb gt1 referenced in describe event or problem and concomitant medical products is being filed under a separate medwatch report.
 
Event Description
It was reported that the procedure was to treat a lesion located in the mid to distal left anterior descending artery (lad). Pre-dilatation was performed with a 3. 0 x 20 mm balloon catheter. The 3. 0 x 28 mm absorb gt1 scaffold delivery system was advanced; however, it would not cross distally; therefore, the scaffold was deployed in the diseased mid lad. The distal section was treated with a 2. 75 x 28 mm xience alpine stent. When optical coherence tomography was performed a large calcified nodule was observed which was distorting the struts of the scaffold; therefore, the decision was made to deploy a 3. 5 x 23 mm xience alpine to cover the distorted struts. This caused an occlusion of the diagonal branch which led to the patient experiencing a myocardial infarction. No treatment was performed for the diagonal occlusion as the vessel could not be rewired. Five (5) days later the patient experienced symptoms of atrial fibrillation and congestive cardiac failure. No additional information was provided.
 
Manufacturer Narrative
(b)(4).
 
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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)
ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168
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 Key6350466
MDR Text Key68059296
Report Number2024168-2017-01438
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 02/22/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/22/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number1120350-23
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 Received02/22/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 02/22/2017 Patient Sequence Number: 1
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