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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR-CARDIAC THERAPIESJOSTENT GRAFTMASTER

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ABBOTT VASCULAR-CARDIAC THERAPIES JOSTENT GRAFTMASTER   Back to Search Results
Catalog Number 12744-12
Device Problems Difficult to insert; Use of Device Issue
Event Date 12/14/2009
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative

 
Event Description

Reporting status: serious injury/medical intervention. Reporting rationale: resistance with a graftmaster is an issue known to require a second device or additional procedure. Device issue: resistance. It was reported that during a lad stenting procedure, the physician implanted a xience v stent, intentionally jailing the 1st diagonal. Post stenting, additional stenosis was noted at the proximal end of the 1st diagonal which the treated via pta using a 2. 5 x 15 rx voyager. During inflation of the balloon, a dissection occurred within the 1st diagonal. The physician attempted to insert the jostent graftmaster device into a 6f sheath (the ifu reads that a 7f sheath should be used). The device would not insert and the physician discarded the device. The device was never deployed/implanted. The physician re-inserted the rx voyager and inflated the balloon at low atm and the dissection resolved successfully without further intervention. There was no patient complications. There is a additional information available.

 
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Brand NameJOSTENT GRAFTMASTER
Manufacturer (Section F)
ABBOTT VASCULAR-CARDIAC THERAPIES
26531 ynez rd.
mailing p.o. box 9018
temecula CA 92591 4628
Manufacturer (Section D)
ABBOTT VASCULAR-CARDIAC THERAPIES
26531 ynez rd.
mailing p.o. box 9018
temecula CA 92591 4628
Manufacturer (Section G)
ABBOTT VASCULAR GERMANY
rudolf-diesel-strasse 29
rangendingen
GERMANY D-72414
Manufacturer Contact
denise vinmans
26531 ynez rd.
temecula , CA 92591-4628
(951) 914 -3997
Device Event Key1620852
MDR Report Key1576664
Event Key1501005
Report Number2024168-2010-00058
Device Sequence Number1
Product CodeMAF
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Remedial Action Other
Type of Report Initial
Report Date 12/17/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/11/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number12744-12
Device LOT Number531029
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Device Age na
Event Location Other
Was The Report Sent To Manufacturer? No
Date Manufacturer Received12/17/2009
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
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 01/11/2010 Patient Sequence Number: 1
#TreatmentTreatment Date
UNK
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