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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTERVASCULAR SAS INTERGARD WOVEN AORTIC ARCH; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

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INTERVASCULAR SAS INTERGARD WOVEN AORTIC ARCH; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER Back to Search Results
Model Number HEWAA2810080810/1
Device Problem Device Damaged Prior to Use (2284)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/04/2021
Event Type  malfunction  
Manufacturer Narrative
It was reported that the product is available for investigation, it should be returned to intervascular for examination.The review of historical data indicated that no other similar complaint was reported for the same sterilization lot number 21b04.The investigation is still ongoing.A follow up report will be sent upon completion of the investigation.
 
Event Description
It was reported: "the cargo is damaged before placing in the warehouse of the airport (b)(6).The amount of damage determined at the warehouse of the recipient." (b)(4).
 
Event Description
See mfg report #1640201-2021-00039.Complaint #(b)(4).On december 16, 2021 we received additional information that the product could not be returned as it was requested by the hospital.The product was implanted.The patient's status is good.The hospital accepted damaged boxes as its only cardboard and the internal packaging was intact without any traces of damages.
 
Manufacturer Narrative
Corrected data: on block d9, it was initially stated that the product was available for evaluation.On december 16, 2021 we received the information that the product could not be returned as it was requested by the hospital.On block h6, the health effect ¿ impact codes "2645" was replaced by "2199" as we received the information that the product was implanted and the patient's status is good.(4117) device is not accessible for testing as it was implanted in the patient.The hospital accepted damaged boxes as its only cardboard and the internal packaging was intact without any traces of damages.(4112/3236) a visual inspection based on pictures received was performed by our quality assurance manager.His conclusion is as follows : "based on the attached photo, i do believe that the box was damaged during shipping." "in the photos, several products are clearly non-compliant due to the damaged box, there is a risk of damage to the sterile barrier." (18) please note that, as per the product instructions for use, contents sterile unless package is opened or damaged.Do not use if sterile barrier is damaged.If damage is found, call your local distributor or getinge representative.(4308) the most probable root cause of this event is an improper handling of the package during transport.An internal non-conformity report has been initiated in order to take appropriate action.H3 other text : 4117 - device implanted.
 
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Brand Name
INTERGARD WOVEN AORTIC ARCH
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
philip gailard
zone industrielle athelia i
la ciotat 13705
FR   13705
442084646
MDR Report Key12923785
MDR Text Key286251280
Report Number1640201-2021-00039
Device Sequence Number1
Product Code DSY
UDI-Device Identifier003844401010753
UDI-Public(01)003844401010753
Combination Product (y/n)N
Reporter Country CodeUP
PMA/PMN Number
K013651
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 01/07/2022
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 NumberHEWAA2810080810/1
Device Catalogue NumberHEWAA2810080810/1
Device Lot Number21G08
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/04/2021
Initial Date FDA Received12/03/2021
Supplement Dates Manufacturer Received12/16/2021
Supplement Dates FDA Received01/07/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured07/08/2021
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient SexPrefer Not To Disclose
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