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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 Problems Thrombosis (2100); No Known Impact Or Consequence To Patient (2692)
Event Date 10/04/2017
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 that approximately 326 days post vascular graft implant, thrombectomy and angioplasty was allegedly performed, resulting in improved graft and vein patency.The event was considered resolved and the subject was discharged from the hospital.New information: it was reported that approximately 465 days post study conduit insertion, the subject experienced thrombosis of vascular access and was hospitalized.A thrombectomy was performed and the hospital status was unknown.
 
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.
 
Event Description
It was reported that approximately 326 days post vascular graft implant, thrombectomy and angioplasty was allegedly performed, resulting in improved graft and vein patency.The event was considered resolved and the subject was discharged from the hospital.It was further reported that approximately 465 days post study conduit insertion, the subject experienced thrombosis of vascular access and was hospitalized.A thrombectomy was performed and the hospital status was unknown.New information: it was reported that approximately 356 days post study conduit insertion, the subject experienced thrombosis of vascular access and a thrombectomy was performed.The event was considered resolved and the subject was discharged on hospital day two.
 
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 for obstruction within the 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 that during a dialysis procedure thrombus was identified in the venous track.A thrombectomy procedure was performed at the anastomosis of the a-v graft.Angioplasty was performed post thrombectomy.The vessel was reported to be patent with good blood flow.There is no indication of a malfunction to the vascular graft.There was no reported patient injury it was reported that approximately 325 days post vascular graft implant the patient was found to have thrombosis of vascular access, was admitted to the hospital and a thrombectomy was scheduled for the following day.At the time of report, the event was considered not resolved and the status of the hospitalization was not provided.There was no indication of a malfunction to the vascular graft.There was no reported patient injury.It was reported that approximately 326 days post vascular graft implant, thrombectomy and angioplasty was allegedly performed, resulting in improved graft and vein patency.The event was considered resolved and the subject was discharged from the hospital.It was reported that approximately 465 days post study conduit insertion, the subject experienced thrombosis of vascular access and was hospitalized.A thrombectomy was performed and the hospital status was unknown.It was reported that approximately 356 days post study conduit insertion, the subject experienced thrombosis of vascular access and a thrombectomy was performed.The event was considered resolved and the subject was discharged on hospital day two.
 
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 for obstruction within the 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.
 
Event Description
It was reported that during a dialysis procedure thrombus was identified in the venous track.A thrombectomy procedure was performed at the anastomosis of the a-v graft.Angioplasty was performed post thrombectomy.The vessel was reported to be patent with good blood flow.There is no indication of a malfunction to the vascular graft.There was no reported patient injury new information received: it was reported that approximately 325 days post vascular graft implant the patient was found to have thrombosis of vascular access, was admitted to the hospital and a thrombectomy was scheduled for the following day.At the time of report, the event was considered not resolved and the status of the hospitalization was not provided.There was no indication of a malfunction to the vascular graft.There was no reported patient injury.New information received: it was reported that approximately 326 days post vascular graft implant, thrombectomy and angioplasty was allegedly performed, resulting in improved graft and vein patency.The event was considered resolved and the subject was discharged from the hospital.New information: it was reported that approximately 465 days post study conduit insertion, the subject experienced thrombosis of vascular access and was hospitalized.A thrombectomy was performed and the hospital status was unknown.New information: it was reported that approximately 356 days post study conduit insertion, the subject experienced thrombosis of vascular access and a thrombectomy was performed.The event was considered resolved and the subject was discharged on hospital day two.New information: it was reported that approximately 717 days post conduit insertion, the subject experienced thrombosis of vascular access and a thrombectomy was performed.The event was considered resolved and the subject was discharged from hospital the next day.
 
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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 Key7489164
MDR Text Key107438982
Report Number2020394-2018-00579
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 11/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/04/2018
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 Received11/04/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
LEVETIRACETAM, EPOETIN BETA; LEVETIRACETAM, EPOETIN BETA; LEVETIRACETAM, EPOETIN BETA; LEVETIRACETAM, EPOETIN BETA; PANTOPRAZOLE, POLOCARD, CIPROFLOXACIN; PANTOPRAZOLE, POLOCARD, CIPROFLOXACIN; PANTOPRAZOLE, POLOCARD, CIPROFLOXACIN; PANTOPRAZOLE, POLOCARD, CIPROFLOXACIN; VINPOCETINUM, KREON, BISOPROLOL FUMARATE; VINPOCETINUM, KREON, BISOPROLOL FUMARATE; VINPOCETINUM, KREON, BISOPROLOL FUMARATE; VINPOCETINUM, KREON, BISOPROLOL FUMARATE; VITAMIN B1, B6 & B12 & C, CALCIUM, ACIDUM FOLICUM; VITAMIN B1, B6 & B12 & C, CALCIUM, ACIDUM FOLICUM; VITAMIN B1, B6 & B12 & C, CALCIUM, ACIDUM FOLICUM; VITAMIN B1, B6 & B12 & C, CALCIUM, ACIDUM FOLICUM
Patient Outcome(s) Hospitalization; Other; Required Intervention;
Patient Age60 YR
Patient Weight44
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