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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR-CARDIAC THERAPIES, ABBOTT VASCULAR GERMANY JOSTENT GRAFTMASTER

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ABBOTT VASCULAR-CARDIAC THERAPIES, ABBOTT VASCULAR GERMANY JOSTENT GRAFTMASTER Back to Search Results
Catalog Number 12745-16
Device Problems Difficult to deploy; Leak
Event Date 08/25/2010
Event Type  Death  
Manufacturer Narrative

(b)(4). The acs multi-link rx ultra coronary stent system (part 1003382-13, lot 00211441) indicated is being filed under a separate medwatch mfr number. Eval summary: factors that can contribute to difficulty deploying a stent due to stent recoil can include, but are not limited to, pt's anatomical morphology, lesion characteristics, pt's disease state, pre-dilatation strategy, inflation technique, product size selection, and/or lesion size. Failure to seal the perforation (the reported leak) may be attributed to several factors including, but not limited to, stent graft foil damage, pt anatomical morphology, product size selection, deployment technique (non-central positioning of stent graft over perforation or inadequate overlapping), interference from previously deployed devices, or growth of perforation during deployment. In this case, it is possible that the graft master stent was too small for the vessel, resulting in difficulty fully apposing the stent to the vessel wall, which may have contributed to the reported stent recoil and further contributing to the failure to seal the perforation; however, this could not be confirmed. It was also reported that after the graftmaster stent was deployed, the perforation was not sealed, and the pt was sent to surgery in an attempt to control the bleeding; however, the pt expired. Due to the inherently serious and emergent use of the graftmaster device, the perforation itself and/or the failure to treat the perforation may have possibly resulted in cascade of pt effects and additional treatments, which ultimately lead to death. Death is a known adverse event as listed in the instructions for use (ifu) and may also be related to the pt's overall health condition, pt disease state and/or treatment strategy at any stage of the perforation. A conclusive cause for these reported pt effects and their relationship to the device, if any, could not be determined. A conclusive cause for the difficulty deploying the stent and failure to seal the perforation could not be determined. A review of the lot history records did not reveal any non-conforming material records associated with this lot and all lot release testing met mfg criteria. During mfg, all stent delivery systems are 100% leak-tested and visually inspected for foil damage and proper placement.

 
Event Description

It was reported that after deployment of a 5. 0 x 13 mm rx ultra stent in a saphenous vein graft to the right coronary artery lesion, a perforation occurred requiring the placement of a graftmaster stent. Initially, the perforation was sealed; however, approx 4-6 hours post procedure, the bleeding restarted and it was found that the graftmaster stent had recoiled. The pt was sent to surgery; however, the attempts to control the bleeding were unsuccessful and the pt expired. Pt's death occurred on (b)(6)2010. No additional event or pt info is available.

 
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Brand NameJOSTENT GRAFTMASTER
Manufacturer (Section F)
ABBOTT VASCULAR-CARDIAC THERAPIES, ABBOTT VASCULAR GERMANY
rudolf-diesel-strasse 29
rangendingen
GERMANY D-72414
Manufacturer (Section D)
ABBOTT VASCULAR-CARDIAC THERAPIES, ABBOTT VASCULAR GERMANY
rudolf-diesel-strasse 29
rangendingen
GERMANY D-72414
Manufacturer (Section G)
ABBOTT VASCULAR GERMANY
rudolf-diesel strasse 29
rangendingen
GERMANY D-72414
Manufacturer Contact
kthleen reily
26531 ynez rd.
temecula , CA 92591-4628
(951) 914 -3996
Device Event Key1880285
MDR Report Key1843959
Event Key1744626
Report Number2024168-2010-01978
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 08/27/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/21/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date04/30/2011
Device Catalogue Number12745-16
Device LOT Number526252
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Was The Report Sent To Manufacturer? No
Date Manufacturer Received08/27/2010
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/01/2008
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? Yes
Is this an Explanted Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 09/21/2010 Patient Sequence Number: 1
Treatment
ACS MULTI-LINK RX ULTRA CORONARY STENT SYSTEM
(PART 1003382-13, LOT 0021141)
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