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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 Problems Occlusion Within Device (1423); Obstruction of Flow (2423)
Patient Problem Thrombosis (2100)
Event Date 10/31/2017
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 one year and three months post placement of a left upper arm vascular graft, the patient experienced thrombosis of vascular access and was hospitalized.Reportedly, angioplasty of the arterial anastomosis was performed followed by the administration of tissue plasminogen activator in the graft; the patient discharged on hospital day two.
 
Event Description
It was reported through the results of a clinical trial, that approximately one year and three months post placement of a left upper arm vascular graft, the patient experienced thrombosis of vascular access and was hospitalized.Reportedly, angioplasty of the arterial anastomosis was performed followed by the administration of tissue plasminogen activator in the graft; the patient discharged on hospital day two.New information: it was reported through the results of a clinical trial, that approximately one year and two months post vascular graft placement, the patient experienced thrombosis of vascular access and was hospitalized.Reportedly, tpa was administered within the graft; followed by angioplasty and stent placement and the event was considered resolved.Approximately one year and six months post vascular graft placement, the patient experienced thrombosis of vascular access and was hospitalized.Reportedly, tpa was administered within the graft, followed by clot removal and angioplasty and the event was considered resolved.
 
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.
 
Manufacturer Narrative
No hospital/medical records or medical images have been made available to the manufacturer.The device has not been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.Manufacturing review: the lot number has been provided and the lot device history records have been reviewed.The lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Expiry date: 01/2021,manufacturing date: 02/2016.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 and three months post placement of a left upper arm vascular graft, the patient experienced thrombosis of vascular access and was hospitalized.Reportedly, angioplasty of the arterial anastomosis was performed followed by the administration of tissue plasminogen activator (tpa) in the graft; the patient discharged on hospital day two.New information: it was reported through the results of a clinical trial, that approximately one year and two months post vascular graft placement, the patient experienced thrombosis of vascular access and was hospitalized.Reportedly, tpa was administered within the graft; followed by angioplasty and stent placement and the event was considered resolved.Approximately one year and six months post vascular graft placement, the patient experienced thrombosis of vascular access and was hospitalized.Reportedly, tpa was administered within the graft, followed by clot removal and angioplasty and the event was considered resolved.New information: it was reported through the results of a clinical trial, that approximately one year and seven months post vascular graft placement, the patient experienced thrombosis of vascular access and was hospitalized.Information regarding treatment was not provided.The patient was discharged on hospital day two.
 
Event Description
It was reported through the results of a clinical trial, that approximately one year and three months post placement of a left upper arm vascular graft, the patient experienced thrombosis of vascular access and was hospitalized.Reportedly, angioplasty of the arterial anastomosis was performed followed by the administration of tissue plasminogen activator (tpa) in the graft; the patient discharged on hospital day two.New information: it was reported through the results of a clinical trial, that approximately one year and two months post vascular graft placement, the patient experienced thrombosis of vascular access and was hospitalized.Reportedly, tpa was administered within the graft; followed by angioplasty and stent placement and the event was considered resolved.Approximately one year and six months post vascular graft placement, the patient experienced thrombosis of vascular access and was hospitalized.Reportedly, tpa was administered within the graft, followed by clot removal and angioplasty and the event was considered resolved.New information: it was reported through the results of a clinical trial, that approximately one year and seven months post vascular graft placement, the patient experienced thrombosis of vascular access and was hospitalized.Information regarding treatment was not provided.The patient was discharged on hospital day two.New information: it was reported through the results of a clinical trial, that approximately eight months post vascular graft placement, the patient experienced stenosis of vascular access.Approximately one year one month post vascular graft placement, the subject experienced stenosis of vascular access.Approximately one year two months post vascular graft placement, the patient experienced thrombosis of vascular access and was hospitalized.The following day, thrombectomy and angioplasty were performed.The venous outflow was widely patent and flow was restored.Two days post hospital admission, the patient was dialyzed and discharged.The current patient status was not provided.New information: it was reported through the results of a clinical trial that approximately one year seven months post vascular graft placement, the patient experienced thrombosis of vascular access and was hospitalized.The patient was offered a de-clotting procedure but declined and opted to have a tunneled line inserted instead.The following day, the patient was dialyzed via the tunneled line and was discharged to be reviewed in the outpatient vascular access clinic.The study conduit was abandoned due to no thrill or audible bruit.
 
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 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.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.(expiry date: 01/2021), (manufacturing date: 02/2016).
 
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 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.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.(expiry date: 01/2021), (manufacturing date: 02/2016).
 
Event Description
It was reported through the results of a clinical trial, that approximately one year and three months post placement of a left upper arm vascular graft, the patient experienced thrombosis of vascular access and was hospitalized.Reportedly, angioplasty of the arterial anastomosis was performed followed by the administration of tissue plasminogen activator (tpa) in the graft; the patient discharged on hospital day two.New information: it was reported through the results of a clinical trial, that approximately one year and two months post vascular graft placement, the patient experienced thrombosis of vascular access and was hospitalized.Reportedly, tpa was administered within the graft; followed by angioplasty and stent placement and the event was considered resolved.Approximately one year and six months post vascular graft placement, the patient experienced thrombosis of vascular access and was hospitalized.Reportedly, tpa was administered within the graft, followed by clot removal and angioplasty and the event was considered resolved.New information: it was reported through the results of a clinical trial, that approximately one year and seven months post vascular graft placement, the patient experienced thrombosis of vascular access and was hospitalized.Information regarding treatment was not provided.The patient was discharged on hospital day two.New information: it was reported through the results of a clinical trial, that approximately eight months post vascular graft placement, the patient experienced stenosis of vascular access.Approximately one year one month post vascular graft placement, the subject experienced stenosis of vascular access.Approximately one year two months post vascular graft placement, the patient experienced thrombosis of vascular access and was hospitalized.The following day, thrombectomy and angioplasty were performed.The venous outflow was widely patent and flow was restored.Two days post hospital admission, the patient was dialyzed and discharged.The current patient status was not provided.New information: it was reported through the results of a clinical trial that approximately one year seven months post vascular graft placement, the patient experienced thrombosis of vascular access and was hospitalized.The patient was offered a de-clotting procedure but declined and opted to have a tunneled line inserted instead.The following day, the patient was dialyzed via the tunneled line and was discharged to be reviewed in the outpatient vascular access clinic.The study conduit was abandoned due to no thrill or audible bruit.
 
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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 Key7612362
MDR Text Key111428048
Report Number2020394-2018-00912
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,Followup,Followup,Followup
Report Date 06/17/2019
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 05/22/2018
Initial Date FDA Received06/18/2018
Supplement Dates Manufacturer Received09/05/2018
10/03/2018
02/12/2019
05/21/2019
Supplement Dates FDA Received10/03/2018
10/30/2018
02/14/2019
06/17/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
BUMETANIDE, SIMVASTATIN, CARVEDILOL, CLOPIDOGREL; BUMETANIDE, SIMVASTATIN, CARVEDILOL, CLOPIDOGREL; BUMETANIDE, SIMVASTATIN, CARVEDILOL, CLOPIDOGREL; BUMETANIDE, SIMVASTATIN, CARVEDILOL, CLOPIDOGREL; BUMETANIDE, SIMVASTATIN, CARVEDILOL, CLOPIDOGREL; RENAL VITAMINS, DARBEPOETIN ALFA, OMEPRAZOLE; RENAL VITAMINS, DARBEPOETIN ALFA, OMEPRAZOLE; RENAL VITAMINS, DARBEPOETIN ALFA, OMEPRAZOLE; RENAL VITAMINS, DARBEPOETIN ALFA, OMEPRAZOLE; RENAL VITAMINS, DARBEPOETIN ALFA, OMEPRAZOLE
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age75 YR
Patient Weight79
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