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 Problems Unspecified Infection (1930); Thrombosis (2100); Stenosis (2263)

Event Date 09/02/2017

Event Type  Injury  

Manufacturer Narrative

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.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 ten months post placement of a right upper arm vascular graft, the patient experienced thrombosis of vascular access and a central venous catheter was inserted for hemodialysis access.It was further reported that the patient admitted to the hospital approximately one week later.Reportedly, a thrombectomy with percutaneous transluminal angioplasty was successfully performed in the venous anastomosis and the patient discharged on hospital day two.

Event Description

It was reported through the results of a clinical trial, that approximately ten months post placement of a right upper arm vascular graft, the patient experienced thrombosis of vascular access and a central venous catheter was inserted for hemodialysis access.It was further reported that the patient admitted to the hospital approximately one week later.Reportedly, a thrombectomy with percutaneous transluminal angioplasty was successfully performed in the venous anastomosis and the patient discharged on hospital day two.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 admitted to the hospital.Reportedly, a thrombectomy and percutaneous transluminal angioplasty were successfully performed.It was reported through the results of a clinical trial, that approximately one year and five months post placement of a right upper arm vascular graft, the patient experienced infection of vascular access and was admitted to the hospital.Reportedly, an operation was performed and part of the study conduit was removed.The current patient status is unknown.

Manufacturer Narrative

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.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

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.This is the only complaint reported to date for this lot number and failure mode.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.

Event Description

It was reported through the results of a clinical trial, that approximately ten months post placement of a right upper arm vascular graft, the patient experienced thrombosis of vascular access and a central venous catheter was inserted for hemodialysis access.It was further reported that the patient admitted to the hospital approximately one week later.Reportedly, a thrombectomy with percutaneous transluminal angioplasty was successfully performed in the venous anastomosis and the patient discharged on hospital day two.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 admitted to the hospital.Reportedly, a thrombectomy and percutaneous transluminal angioplasty were successfully performed.It was reported through the results of a clinical trial, that approximately one year and five months post placement of a right upper arm vascular graft, the patient experienced infection of vascular access and was admitted to the hospital.Reportedly, an operation was performed and part of the study conduit was removed.The current patient status is unknown.It was reported through the results of a clinical trial, that approximately four months post placement of a right upper arm vascular graft, the patient experienced thrombosis and stenosis of vascular access.Approximately one year two months post vascular graft placement the patient experienced thrombosis of vascular access, was hospitalized, and a central venous catheter was placed.Reportedly, thrombectomy and angioplasty procedures were performed and the catheter was removed.The patient was discharged approximately one week post admission.

Event Description

It was reported through the results of a clinical trial, that approximately ten months post placement of a right upper arm vascular graft, the patient experienced thrombosis of vascular access and a central venous catheter was inserted for hemodialysis access.It was further reported that the patient admitted to the hospital approximately one week later.Reportedly, a thrombectomy with percutaneous transluminal angioplasty was successfully performed in the venous anastomosis and the patient discharged on hospital day two.New information: 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 admitted to the hospital.Reportedly, a thrombectomy and percutaneous transluminal angioplasty were successfully performed.

Manufacturer Narrative

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.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 ten months post placement of a right upper arm vascular graft, the patient experienced thrombosis of vascular access and a central venous catheter was inserted for hemodialysis access.It was further reported that the patient admitted to the hospital approximately one week later.Reportedly, a thrombectomy with percutaneous transluminal angioplasty was successfully performed in the venous anastomosis and the patient discharged on hospital day two.New information: 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 admitted to the hospital.Reportedly, a thrombectomy and percutaneous transluminal angioplasty were successfully performed.New information: it was reported through the results of a clinical trial, that approximately one year and five months post placement of a right upper arm vascular graft, the patient experienced infection of vascular access and was admitted to the hospital.Reportedly, an operation was performed and part of the study conduit was removed.The current patient status is unknown.New information: it was reported through the results of a clinical trial, that approximately four months post placement of a right upper arm vascular graft, the patient experienced thrombosis and stenosis of vascular access.Approximately one year two months post vascular graft placement the patient experienced thrombosis of vascular access, was hospitalized, and a central venous catheter was placed.Reportedly, thrombectomy and angioplasty procedures were performed and the catheter was removed.The patient was discharged approximately one week post admission.

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.This is the only complaint reported to date for this lot number and failure mode.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.

• 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: 7430114
• MDR Text Key: 105443194
• Report Number: 2020394-2018-00388
• 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: 02/12/2019

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 Expiration Date: 01/19/2021
• Device Model Number: 40S06
• Device Catalogue Number: 40S06
• Device Lot Number: VTAN0526
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/26/2018
• Initial Date FDA Received: 04/13/2018
• Supplement Dates Manufacturer Received: 07/17/2018; 09/12/2018; 10/01/2018; 02/07/2019
• Supplement Dates FDA Received: 08/15/2018; 10/08/2018; 10/29/2018; 02/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ACETYLSALICYLIC ACID; ACETYLSALICYLIC ACID, ENOXAPARIN SODIUM; CLONIDINE, BISOPROLOL, FUROSEMIDE; CLONIDINE, BISOPROLOL, FUROSEMIDE; CLONIDINE, BISOPROLOL, FUROSEMIDE, ASA; CLONIDINE, BISOPROLOL, FUROSEMIDE, ASA; CLONIDINE, BISOPROLOL, FUROSEMIDE, ASA; CLONIDINE, BISOPROLOL, FUROSEMIDE, ASA
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 48 YR
• Patient Weight: 82