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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AV-TEMECULA-CT ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM DRUG ELUTING CORONARY STENT SYSTEM

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AV-TEMECULA-CT ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM DRUG ELUTING CORONARY STENT SYSTEM Back to Search Results
Catalog Number 1012462-18
Device Problems Material Rupture; Physical Resistance
Event Date 07/07/2015
Event Type  Malfunction  
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. Though the device is not approved for sale in the u. S. , it uses a delivery system which is similar to a device sold in the u. S.

 
Event Description

It was reported that the procedure was to treat a lesion located in the mildly tortuous, moderately calcified left anterior descending artery. After pre-dilatation was performed on the lesion, the 2. 5 x 18 mm delivery system was advanced to the lesion; however, met some resistance during advancement due to calcification proximal to the lesion. The delivery system crossed the lesion; however, the balloon ruptured at between 3-4 atmospheres when pressurized. The implant was not deployed and was removed fully crimped on the balloon from the patient. A xience drug eluting stent was used and deployed successfully for treatment. The patient outcome was good. No adverse patient effects or clinically significant delay in the procedure were reported. No additional information was provided.

 
Manufacturer Narrative

(b)(4). Evaluation summary: the device was returned for evaluation. The balloon rupture/proximal balloon separation was confirmed. The reported resistance during advancement could not be replicated in a testing environment as it was based on operational circumstances. Based on visual and dimensional analysis of the returned device, there is no indication of a product quality issue with respect to manufacture, design or labeling. 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 did not indicate a lot specific quality issue. Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling. (b)(4).

 
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Brand NameABSORB BIORESORBABLE VASCULAR SCAFFOLD 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 Key4958052
Report Number2024168-2015-04320
Device Sequence Number1
Product CodeNIQ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation HEALTH PROFESSIONAL
Remedial Action Other
Type of Report Initial,Followup
Report Date 09/02/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/31/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date05/31/2016
Device Catalogue Number1012462-18
Device LOT Number412046A
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/10/2015
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/24/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/01/2014
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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