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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 Problems Occlusion Within Device (1423); Obstruction of Flow (2423)
Patient Problems Thrombosis (2100); Stenosis (2263)
Event Date 07/09/2017
Event Type  Injury  
Manufacturer Narrative
Manufacturing review: as the lot number for the device was not provided, a manufacturing review could not be performed.Investigation summary: the device was not returned for evaluation.Images and medical records were not provided for review.Therefore, the investigation is inconclusive 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.Labeling review: 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.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 seven months post placement of a left forearm vascular graft, the patient experienced stenosis of vascular access of the venous and arterial anastomosis and thrombosis of vascular access.Reportedly, percutaneous transluminal angioplasty and a thrombectomy was performed; final angiogram revealed good flow.
 
Event Description
It was reported through the results of a clinical trial, that approximately seven months post placement of a left forearm vascular graft, the patient experienced stenosis of vascular access of the venous and arterial anastomosis and thrombosis of vascular access.Reportedly, percutaneous transluminal angioplasty and a thrombectomy was performed; final angiogram revealed good flow.
 
Manufacturer Narrative
As the lot number for the device was not provided, a manufacturing review could not be performed.The device was not returned for evaluation.Images and medical records were not provided for review.Therefore, the investigation is inconclusive 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.
 
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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 Key7580886
MDR Text Key110447305
Report Number2020394-2018-00823
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 health professional,study
Type of Report Initial,Followup
Report Date 08/21/2018
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 NumberUNKNOWN
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 05/16/2018
Initial Date FDA Received06/07/2018
Supplement Dates Manufacturer Received07/24/2018
Supplement Dates FDA Received08/21/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
AMLODIPINE-VALSARTAN, RENA-VITE, SIMVASTATIN; AMLODIPINE-VALSARTAN, RENA-VITE, SIMVASTATIN; CALCIUM ACETATE, GLIMEPIRIDE, METOCLOPRAMIDE, ASA; CALCIUM ACETATE, GLIMEPIRIDE, METOCLOPRAMIDE, ASA
Patient Outcome(s) Required Intervention;
Patient Age66 YR
Patient Weight69
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