MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. IMPRA EPTFE VASCULAR GRAFT

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.

• 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 Key: 7612362
• MDR Text Key: 111428048
• Report Number: 2020394-2018-00912
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00801741021831
• UDI-Public: (01)00801741021831
• Combination Product (y/n): N
• PMA/PMN Number: K004011
• Number of Events Reported: 1
• 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 Number: 40S06
• Device Catalogue Number: 40S06
• Device Lot Number: VTAP0037
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/22/2018
• Initial Date FDA Received: 06/18/2018
• Supplement Dates Manufacturer Received: 09/05/2018; 10/03/2018; 02/12/2019; 05/21/2019
• Supplement Dates FDA Received: 10/03/2018; 10/30/2018; 02/14/2019; 06/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• 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 Age: 75 YR
• Patient Weight: 79