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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. IMPRA VASCULAR GRAFT; EPTFE VASCULAR GRAFT
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BARD PERIPHERAL VASCULAR, INC. IMPRA VASCULAR GRAFT; EPTFE VASCULAR GRAFT Back to Search Results
Model Number 40S06
Device Problem Obstruction of Flow (2423)
Patient Problem Thrombosis/Thrombus (4440)
Event Date 11/04/2020
Event Type  Injury  
Manufacturer Narrative
As the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.(expiry date: 01/2021).
 
Event Description
It was reported through the results of a clinical trial, approximately 1420 days post study conduit implant, the subject experienced thrombosis of the vascular access.A thrombectomy procedure was performed and the event was considered resolved.The current status of the subject was not provided.
 
Manufacturer Narrative
Manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the physical device was not returned for evaluation.No photos were provided for review.Therefore, the investigation is inconclusive for the reported failure as no objective evidence was provided for review.A definitive root cause for the alleged thrombosis of vascular access could not be determined based upon the provided information.Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.Expiry date: 01/2021.Section a through f ¿ the information provide by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
 
Event Description
It was reported through the results of a clinical trial, approximately 1420 days post study conduit implant, the subject experienced thrombosis of the vascular access.A thrombectomy procedure was performed and the event was considered resolved.The current status of the subject was not provided.
 
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Brand Name
IMPRA VASCULAR GRAFT
Type of Device
EPTFE VASCULAR GRAFT
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
MDR Report Key10964543
MDR Text Key220162699
Report Number2020394-2020-20774
Device Sequence Number1
Product Code DSY
UDI-Device Identifier00801741021831
UDI-Public(01)00801741021831
Combination Product (y/n)N
PMA/PMN Number
K004011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,study
Type of Report Initial,Followup
Report Date 06/15/2021
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 Health Professional
Device Model Number40S06
Device Catalogue Number40S06
Device Lot NumberVTAP0037
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/11/2020
Initial Date FDA Received12/08/2020
Supplement Dates Manufacturer Received06/16/2021
Supplement Dates FDA Received06/23/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ACETYLSALICYLIC ACID; ACETYLSALICYLIC ACID; NITRENDIPINE, PANTOPRAZOLE; NITRENDIPINE, PANTOPRAZOLE; ACETYLSALICYLIC ACID; NITRENDIPINE, PANTOPRAZOLE
Patient Outcome(s) Other;
Patient Age62 YR
Patient Weight53
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