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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTERVASCULAR SAS HEMAGARD KNITTED GRAFT; VASCULAR GRAFT PROSTHESIS

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INTERVASCULAR SAS HEMAGARD KNITTED GRAFT; VASCULAR GRAFT PROSTHESIS Back to Search Results
Model Number HGK0008-70
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem Death (1802)
Event Date 06/26/2015
Event Type  malfunction  
Event Description
During a right axilofemoral by-pass surgery performed on (b)(6) 2015, it was noted that the graft had a very high permeability and was not retaining the fluid.The graft was not implanted.The surgery was completed with another graft.The patient died with no link established between the graft and the patient death.
 
Manufacturer Narrative
A review of the device history records, including collagen coating records, indicated that the graft was processed and inspected according to procedures and no anomaly was found.Specifically, the review of the water permeability testing records of products coated on the same day and under the same conditions as the complaint device indicated values well within product specifications.One retention sample coated on the same period and under the same conditions as the complaint device underwent water permeability testing at 120mmhg as per iso 7198.The test result indicated a value well within product specifications.The returned device was sent to an outside laboratory for scanning electron microscopy analysis.The investigation is still on going.A follow-up report will be submitted upon completion of the investigation.
 
Manufacturer Narrative
The product was not used at it was suspected to present a high porosity the complaint device has been sent to an outside laboratory for macroscopic and scanning electron microscopy (sem) evaluation.The sem analysis showed no significant abnormality such as tear, extensive filament rupture, sectioning, loss of the textile cohesion or hole, neither macroscopically nor ultrastructurally.The presence of collagen was confirmed.No conclusion can be drawn.However, all available information and the product testing performed would tend to indicate that the device was not defective.
 
Event Description
The graft was suspected to have a very high permeability and was not used at all.
 
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Brand Name
HEMAGARD KNITTED GRAFT
Type of Device
VASCULAR GRAFT PROSTHESIS
Manufacturer (Section D)
INTERVASCULAR SAS
zi athelia 1
la ciotat cedex, 13705
FR  13705
Manufacturer (Section G)
INTERVASCULAR SAS
zi athelia 1
la ciotat cedex, 13705
FR   13705
Manufacturer Contact
pascal de framond
zi athelia 1
la ciotat cedex, 13705
FR   13705
3344208779
MDR Report Key4939033
MDR Text Key6036078
Report Number1640201-2015-00027
Device Sequence Number1
Product Code DSY
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
K964625
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative,Distributor,company representative
Reporter Occupation Physician
Type of Report Initial
Report Date 06/26/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date05/31/2019
Device Model NumberHGK0008-70
Device Catalogue NumberHGK0008-70
Device Lot Number14F19
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/09/2015
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/26/2015
Initial Date FDA Received07/24/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
CEFAZOLIN; ACETYLSALICYLIQUE ACID; RIFAMPICIN
Patient Outcome(s) Required Intervention;
Patient Age73 YR
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