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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 Problems Thrombosis (2100); Stenosis (2263)
Event Date 09/19/2017
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 and three months post placement of a right upper arm vascular graft, the patient experienced thrombosis of vascular access and was hospitalized.Reportedly, angioplasty, thrombectomy and stent placement was performed; the patient discharged on hospital day six.
 
Event Description
It was reported through the results of a clinical trial, that approximately one year and three months post placement of a right upper arm vascular graft, the patient experienced thrombosis of vascular access and was hospitalized.Reportedly, angioplasty, thrombectomy and stent placement was performed; the patient discharged on hospital day six.New information: it was reported through the results of a clinical trial, that approximately one year and five months post vascular graft placement , the patient experienced thrombosis of vascular access and was hospitalized.Reportedly, angioplasty was performed and the event was considered resolved.New information: it was reported through the results of a clinical trial that approximately six months post vascular graft placement the patient experienced stenosis of vascular access.
 
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.
 
Event Description
It was reported through the results of a clinical trial, that approximately one year and three months post placement of a right upper arm vascular graft, the patient experienced thrombosis of vascular access and was hospitalized.Reportedly, angioplasty, thrombectomy and stent placement was performed; the patient discharged on hospital day six.It was reported through the results of a clinical trial, that approximately one year and five months post vascular graft placement, the patient experienced thrombosis of vascular access and was hospitalized.Reportedly, angioplasty was performed 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
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.
 
Event Description
It was reported through the results of a clinical trial, that approximately one year and three months post placement of a right upper arm vascular graft, the patient experienced thrombosis of vascular access and was hospitalized.Reportedly, angioplasty, thrombectomy and stent placement was performed; the patient discharged on hospital day six.New information: it was reported through the results of a clinical trial, that approximately one year and five months post vascular graft placement, the patient experienced thrombosis of vascular access and was hospitalized.Reportedly, angioplasty was performed and the event was considered resolved.New information: it was reported through the results of a clinical trial that approximately six months post vascular graft placement the patient experienced stenosis of vascular access.New information: it was reported through the results of a clinical trial that approximately one year and nine months post vascular graft placement the patient experienced thrombosis of vascular access and was hospitalized.Reportedly, angiogram, thrombectomy, and angioplasty were performed.The patient was discharged three days post admission and the event was considered resolved.
 
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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 Key7723579
MDR Text Key115137651
Report Number2020394-2018-01290
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
Report Date 07/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/26/2018
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 Received06/14/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ALFACALCIDOL, RANITIDINE, LATANOPROST, CODEINE; ALFACALCIDOL, RANITIDINE, LATANOPROST, CODEINE; ALFACALCIDOL, RANITIDINE, LATANOPROST, CODEINE; ALFACALCIDOL, RANITIDINE, LATANOPROST, CODEINE; BUPRENORPHINE, DARBEPOETIN ALFA, CALCIUM; BUPRENORPHINE, DARBEPOETIN ALFA, CALCIUM; BUPRENORPHINE, DARBEPOETIN ALFA, CALCIUM; BUPRENORPHINE, DARBEPOETIN ALFA, CALCIUM; DOXAZOSIN, FUROSEMIDE, INSULIN, MOXONIDINE; DOXAZOSIN, FUROSEMIDE, INSULIN, MOXONIDINE; DOXAZOSIN, FUROSEMIDE, INSULIN, MOXONIDINE; DOXAZOSIN, FUROSEMIDE, INSULIN, MOXONIDINE; PARACETAMOL, SIMVASTATIN, AMLODIPINE, CLOPIDOGREL; PARACETAMOL, SIMVASTATIN, AMLODIPINE, CLOPIDOGREL; PARACETAMOL, SIMVASTATIN, AMLODIPINE, CLOPIDOGREL; PARACETAMOL, SIMVASTATIN, AMLODIPINE, CLOPIDOGREL; ALFACALCIDOL, RANITIDINE, LATANOPROST, CODEINE; BUPRENORPHINE, DARBEPOETIN ALFA, CALCIUM; DOXAZOSIN, FUROSEMIDE, INSULIN, MOXONIDINE; PARACETAMOL, SIMVASTATIN, AMLODIPINE, CLOPIDOGREL
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age71 YR
Patient Weight76
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