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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. IMPRA EPTFE VASCULAR GRAFT
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BARD PERIPHERAL VASCULAR, INC. IMPRA EPTFE VASCULAR GRAFT Back to Search Results
Model Number 40S06
Device Problem Obstruction of Flow (2423)
Patient Problem Stenosis (2263)
Event Date 01/09/2018
Event Type  Injury  
Manufacturer Narrative
As the lot number for the device was not provided, a manufacturing review could not 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.The information provided by bard represents all of 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 bard.
 
Event Description
It was reported through the results of a clinical trial that approximately one year six months post vascular graft placement in the upper arm, the subject experienced stenosis within the graft anastomosis and was admitted to the hospital.Reportedly, angioplasty was performed and follow-up imaging demonstrated no stenosis within the graft anastomosis.The event was considered resolved and the subject was discharged from the hospital the following day.
 
Manufacturer Narrative
A complete manufacturing review could not be conducted for the investigation as the lot number is unknown.The device was not returned for evaluation.Images and medical records were not provided for review.Therefore, the investigation is inconclusive for obstruction within device as no objective evidence has been provided to confirm any alleged deficiency with the device.Based upon the available information, the definitive root cause is unknown.A review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, and unit label) showed that the product labeling is adequate.
 
Event Description
It was reported through the results of a clinical trial that approximately one year six months post vascular graft placement in the upper arm, the subject experienced stenosis within the graft anastomosis and was admitted to the hospital.Reportedly, angioplasty was performed and follow-up imaging demonstrated no stenosis within the graft anastomosis.The event was considered resolved and the subject was discharged from the hospital the following day.It was reported through the results of a clinical trial that approximately one year post vascular graft placement, the subject experienced stenosis of vascular access.Approximately one year six months post vascular graft placement, the subject experienced stenosis of vascular access.
 
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Brand Name
IMPRA EPTFE VASCULAR GRAFT
Type of Device
EPTFE VASCULAR GRAFT
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
MDR Report Key7943266
MDR Text Key123045813
Report Number2020394-2018-01870
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,health professional,s
Type of Report Initial,Followup
Report Date 11/29/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/08/2018
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 NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received11/01/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ACETYLSALICYLIC ACID, PENTOXIFYLLINE, PANTOPRAZOLE; ACETYLSALICYLIC ACID, PENTOXIFYLLINE, PANTOPRAZOLE; AMLODIPINE, METOPROLOL, FUROSEMIDE, ATORVASTATIN; AMLODIPINE, METOPROLOL, FUROSEMIDE, ATORVASTATIN; CLOPIDOGREL, CALCIUM ACETATE, ALFACALCIDOL; CLOPIDOGREL, CALCIUM ACETATE, ALFACALCIDOL; ISOPHANE INSULIN, INSULIN LISPRO, RAMIPRIL; ISOPHANE INSULIN, INSULIN LISPRO, RAMIPRIL; TRIMEBUTINE
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age50 YR
Patient Weight66
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