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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTERVASCULAR SAS INTERGARD KNITTED AXILLO-BIFEMORAL RADIALLY SUPPORTED; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

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INTERVASCULAR SAS INTERGARD KNITTED AXILLO-BIFEMORAL RADIALLY SUPPORTED; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER Back to Search Results
Model Number IGKAX100808RS35/20
Device Problem Use of Device Problem (1670)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/01/2023
Event Type  malfunction  
Manufacturer Narrative
(10/3233) it was reported that a fragment of the graft that was not implanted in the patient is available.It will be returned for inspection.(4109/213) the review of historical data indicated that no other similar complaint was reported for the same sterilization lot number 23e04.(3331/3233) the device history records review is ongoing, results are pending.(11) the investigation is still ongoing.A follow up report will be sent upon completion.
 
Event Description
It was reported to intervascular that during an axillo bi-femoral bypass procedure, the graft was sewn in at the top end and then the surgeon injected saline solution to test the anastomoses before securing at the bottom end.The surgeon noticed leaking in several places.Additional information provided by the initial reporter indicates that they had suture the top and the axillary and was testing the anastomoses; one side of the graft was fine but the side branch leak was unusual which the surgeon believed was excessive.The surgery was not delayed since the leaking part was removed and replaced by an albo polyester graft 40cm length by 8mm width.The surgeon has over 20 years of experience and has often used intergard products.He has always performed the procedure in the same way and has never noticed this before.There was no harm or injury to the patient.
 
Manufacturer Narrative
(10/213) a fragment of the involved device was returned to intervascular for examination.Two visual inspections of the returned product were performed, the first inspection was carried out in the presence of a trained quality control (qc) technician, the production and quality assurance (qa) supervisors, and the second inspection was in presence of the textile engineer and the qa supervisor.The observation results concluded that, the fragment corresponds to a cut section of the axillo rs branch.No anomalies including structural defects were observed on the returned fragment.(67) the conducted investigation concludes that the returned product fragment is in compliance with the product specifications.
 
Event Description
Complaint # (b)(4).
 
Manufacturer Narrative
(3331/213) the device history records review concluded that no deviation was identified in relation with the reported event.(11) the investigation is still ongoing.A follow up report will be sent upon completion.
 
Event Description
Complaint (b)(4).
 
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Brand Name
INTERGARD KNITTED AXILLO-BIFEMORAL RADIALLY SUPPORTED
Type of Device
PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
Manufacturer (Section D)
INTERVASCULAR SAS
zone industrielle athelia i
la ciotat 13705
FR  13705
Manufacturer (Section G)
INTERVASCULAR SAS
zone industrielle athelia i
la ciotat 13705
FR   13705
Manufacturer Contact
clemence vaneenoge
zone industrielle athelia i
la ciotat 13705
FR   13705
442084646
MDR Report Key17816706
MDR Text Key324239621
Report Number1640201-2023-00029
Device Sequence Number1
Product Code DSY
UDI-Device Identifier00384401006039
UDI-Public00384401006039
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K964625
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Nurse
Type of Report Initial,Followup,Followup
Report Date 12/19/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberIGKAX100808RS35/20
Device Catalogue NumberIGKAX100808RS35/20
Device Lot Number23E04
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/01/2023
Initial Date FDA Received09/26/2023
Supplement Dates Manufacturer Received10/05/2023
11/24/2023
Supplement Dates FDA Received10/26/2023
12/19/2023
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/04/2023
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Age70 YR
Patient SexMale
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