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

BARD PERIPHERAL VASCULAR, INC. IMPRA VASCULAR GRAFT; EPTFE VASCULAR GRAFT

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Model Number 40S06

Device Problem Leak/Splash (1354)

Patient Problems Fever (1858); Unspecified Infection (1930); Seroma (2069); Thrombosis (2100); Chills (2191)

Event Date 09/01/2016

Event Type Injury

Manufacturer Narrative

No medical records or no medical images have been made available to the manufacturer.As the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.Clinical trial review: an av graft was placed in the right upper arm as a study conduit for a clinical trial.Approximately two weeks post graft placement, the patient presented with a seroma and drainage from the graft at the antecubital fossa level.The patient was scheduled for repair of the graft and excision of the seroma.The graft site was opened and irrigated with heparin solution and the seroma was evacuated.A surgical adhesive was applied to the graft due to sweating.The patient tolerated the procedure well and was discharged on hospital day two.Approximately two months post graft placement, the subject developed fever and chills with purulent drainage and tenderness along the graft site.An ultrasound was performed and demonstrated a weeping fluid collection along the graft site.The wound was closed with a surgical adhesive.The patient subsequently was started on iv antibiotics and was admitted to the hospital for infection of vascular access.The patient underwent incision and drainage of the right arm wound with placement of a wound vac.There was a good thrill and bruit in the graft , which was functioning and remained as the patient¿s dialysis access.The patient was discharged in stable condition on hospital day eight.(b)(4).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 two weeks post right upper arm av graft placement, the patient presented with a seroma with drainage at the graft site.The seroma was excised and the graft was repaired due to sweating.The patient tolerated the procedure well and was discharged on hospital day two.Approximately two months post graft placement, the patient developed symptoms of fever and chills with purulent drainage and tenderness along the graft site.The patient was started on antibiotics and was admitted to the hospital for infection and underwent incision and drainage of the wound with placement of a wound vacuum assisted closure.The patient was discharged in stable condition on hospital day eight.

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 event reported to date for this lot number and failure mode.Visual/microscopic inspection: as the device was not returned, an inspection could not be performed.Functional/performance evaluation: as the device was not returned, an evaluation could not be performed.Image/photo review: as medical images and photos were not provided, a review could not be performed.Clinical trial review: an av graft was placed in the right upper arm as a study conduit for a clinical trial.Approximately two weeks post graft placement, the patient presented with a seroma and drainage from the graft at the antecubital fossa level.The patient was scheduled for repair of the graft and excision of the seroma.The graft site was opened and irrigated with heparin solution and the seroma was evacuated.A surgical adhesive was applied to the graft due to sweating.The patient tolerated the procedure well and was discharged on hospital day two.Approximately two months post graft placement, the subject developed fever and chills with purulent drainage and tenderness along the graft site.An ultrasound was performed and demonstrated a weeping fluid collection along the graft site.The wound was closed with a surgical adhesive.The patient subsequently was started on iv antibiotics and was admitted to the hospital for infection of vascular access.The patient underwent incision and drainage of the right arm wound with placement of a wound vac.There was a good thrill and bruit in the graft , which was functioning and remained as the patient¿s dialysis access.The patient was discharged in stable condition on hospital day eight.Approximately six months post graft placement, the patient presented for hemodialysis and arteriovenous access was difficult to obtain.The patient was hospitalized and underwent angioplasty and stent placement.Under ultrasound guidance, access was gained towards the arterial end of the av graft and a 6 french sheath was placed into the right brachiocephalic artery.An angiogram was performed and demonstrated the main runoff was via the radial artery to the hand.There was a peri anastomotic high-grade stenosis of the brachial artery and 80% stenosis of the distal brachial artery which was completely separate from the av graft site.Angioplasty near the proximal brachial artery where the av graft had been anastomosed was performed with a 5 mm balloon.Angioplasty of the right distal brachial artery 10 cm separate from the av graft site was performed with a 4 mm x 8 cm balloon.Follow up imaging demonstrated no significant residual stenosis, although an injection of the av graft demonstrated a majority of the flow going out the graft and not down the hand.Therefore, a 6 french sheath was placed a few centimeters from the av graft access site.Circumferential control was obtained and a 7 mm x 2.5 cm balloon expandable stent (other manufacturer) was placed.There was a palpable radial pulse and significantly more flow down the hand.The patient tolerated the procedure well and had significant improvement in the blood flow to the hand.The patient was discharged the next day with scheduled dialysis.Conclusion: the investigation can be confirmed for a leak at the graft.It can also be confirmed that the patient had an infection in the area of the graft however the relationship to the graft itself is unknown.Per the reported clinical trial results, the graft was flushed with heparin.Per ifu, "exposure to solutions may result in loss of graft's hydrophobic properties.Loss of the hydrophobic barrier may result in graft wall leakage." therefore, the integrity of the graft could have been compromised.However, the definitive root cause is unknown.Labeling review: the current ifu (instructions for use) states: warnings: aggressive and/or excessive graft manipulation when tunneling, or placement within a too tight or too small tunnel, may lead to separation of the spiral beading and/or graft breakage.Avoid repeated or excessive clamping at the same location on the graft.If clamping is necessary, use only atraumatic or appropriate vascular smooth jawed clamps to avoid damage to the graft wall.Exposure to solutions (e.G., alcohol, oil, aqueous solutions, etc.) may result in loss of the graft¿s hydrophobic properties.Loss of the hydrophobic barrier may result in graft wall leakage.Preclotting of this graft is unnecessary.Avoid excessive graft manipulation after exposure to blood or body fluids.Do not forcibly inject any solution through the lumen of the graft, or fill the graft with fluid prior to pulling it through the tunnel as loss of the graft¿s hydrophobic properties may occur.Loss of the hydrophobic barrier may result in graft wall leakage.(b)(4).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

Manufacturer Narrative

This event (2020394-2017-00067) was identified to be the same event as reported on mw 2020394-2016-00963.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 event reported to date for this lot number and failure mode.Visual/microscopic inspection: as the device was not returned, an inspection could not be performed.Functional/performance evaluation: as the device was not returned, an evaluation could not be performed.Image/photo review: as medical images and photos were not provided, a review could not be performed.Clinical trial review: an av graft was placed in the right upper arm as a study conduit for a clinical trial.Approximately two weeks post graft placement, the patient presented with a seroma and drainage from the graft at the antecubital fossa level.The patient was scheduled for repair of the graft and excision of the seroma.The graft site was opened and irrigated with heparin solution and the seroma was evacuated.A surgical adhesive was applied to the graft due to sweating.The patient tolerated the procedure well and was discharged on hospital day two.Approximately two months post graft placement, the subject developed fever and chills with purulent drainage and tenderness along the graft site.An ultrasound was performed and demonstrated a weeping fluid collection along the graft site.The wound was closed with a surgical adhesive.The patient subsequently was started on iv antibiotics and was admitted to the hospital for infection of vascular access.The patient underwent incision and drainage of the right arm wound with placement of a wound vac.There was a good thrill and bruit in the graft , which was functioning and remained as the patient¿s dialysis access.The patient was discharged in stable condition on hospital day eight.Approximately six months post graft placement, the patient presented for hemodialysis and arteriovenous access was difficult to obtain.The patient was hospitalized and underwent angioplasty and stent placement.Under ultrasound guidance, access was gained towards the arterial end of the av graft and a 6 french sheath was placed into the right brachiocephalic artery.An angiogram was performed and demonstrated the main runoff was via the radial artery to the hand.There was a peri anastomotic high-grade stenosis of the brachial artery and 80% stenosis of the distal brachial artery which was completely separate from the av graft site.Angioplasty near the proximal brachial artery where the av graft had been anastomosed was performed with a 5 mm balloon.Angioplasty of the right distal brachial artery 10 cm separate from the av graft site was performed with a 4 mm x 8 cm balloon.Follow up imaging demonstrated no significant residual stenosis, although an injection of the av graft demonstrated a majority of the flow going out the graft and not down the hand.Therefore, a 6 french sheath was placed a few centimeters from the av graft access site.Circumferential control was obtained and a 7 mm x 2.5 cm balloon expandable stent (other manufacturer) was placed.There was a palpable radial pulse and significantly more flow down the hand.The patient tolerated the procedure well and had significant improvement in the blood flow to the hand.The patient was discharged the next day with scheduled dialysis.Conclusion: the investigation can be confirmed for a leak at the graft.It can also be confirmed that the patient had an infection in the area of the graft however the relationship to the graft itself is unknown.Per the reported clinical trial results, the graft was flushed with heparin.Per ifu, "exposure to solutions may result in loss of graft's hydrophobic properties.Loss of the hydrophobic barrier may result in graft wall leakage." therefore, the integrity of the graft could have been compromised.However, the definitive root cause is unknown.Labeling review: the current ifu (instructions for use) states: warnings: aggressive and/or excessive graft manipulation when tunneling, or placement within a too tight or too small tunnel, may lead to separation of the spiral beading and/or graft breakage.Avoid repeated or excessive clamping at the same location on the graft.If clamping is necessary, use only atraumatic or appropriate vascular smooth jawed clamps to avoid damage to the graft wall.Exposure to solutions (e.G., alcohol, oil, aqueous solutions, etc.) may result in loss of the graft¿s hydrophobic properties.Loss of the hydrophobic barrier may result in graft wall leakage.Preclotting of this graft is unnecessary.Avoid excessive graft manipulation after exposure to blood or body fluids.Do not forcibly inject any solution through the lumen of the graft, or fill the graft with fluid prior to pulling it through the tunnel as loss of the graft¿s hydrophobic properties may occur.Loss of the hydrophobic barrier may result in graft wall leakage.(b)(4).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

Manufacturer Narrative

This event (2020394-2017-00067) was identified to be the same event as reported on mw 2020394-2016-00963.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 event reported to date for this lot number and failure mode.Visual/microscopic inspection: as the device was not returned, an inspection could not be performed.Functional/performance evaluation: as the device was not returned, an evaluation could not be performed.Image/photo review: as medical images and photos were not provided, a review could not be performed.Clinical trial review: an av graft was placed in the right upper arm as a study conduit for a clinical trial.Approximately two weeks post graft placement, the patient presented with a seroma and drainage from the graft at the antecubital fossa level.The patient was scheduled for repair of the graft and excision of the seroma.The graft site was opened and irrigated with heparin solution and the seroma was evacuated.A surgical adhesive was applied to the graft due to sweating.The patient tolerated the procedure well and was discharged on hospital day two.Approximately two months post graft placement, the subject developed fever and chills with purulent drainage and tenderness along the graft site.An ultrasound was performed and demonstrated a weeping fluid collection along the graft site.The wound was closed with a surgical adhesive.The patient subsequently was started on iv antibiotics and was admitted to the hospital for infection of vascular access.The patient underwent incision and drainage of the right arm wound with placement of a wound vac.There was a good thrill and bruit in the graft , which was functioning and remained as the patient¿s dialysis access.The patient was discharged in stable condition on hospital day eight.Approximately six months post graft placement, the patient presented for hemodialysis and arteriovenous access was difficult to obtain.The patient was hospitalized and underwent angioplasty and stent placement.Under ultrasound guidance, access was gained towards the arterial end of the av graft and a 6 french sheath was placed into the right brachiocephalic artery.An angiogram was performed and demonstrated the main runoff was via the radial artery to the hand.There was a peri anastomotic high-grade stenosis of the brachial artery and 80% stenosis of the distal brachial artery which was completely separate from the av graft site.Angioplasty near the proximal brachial artery where the av graft had been anastomosed was performed with a 5 mm balloon.Angioplasty of the right distal brachial artery 10 cm separate from the av graft site was performed with a 4 mm x 8 cm balloon.Follow up imaging demonstrated no significant residual stenosis, although an injection of the av graft demonstrated a majority of the flow going out the graft and not down the hand.Therefore, a 6 french sheath was placed a few centimeters from the av graft access site.Circumferential control was obtained and a 7 mm x 2.5 cm balloon expandable stent (other manufacturer) was placed.There was a palpable radial pulse and significantly more flow down the hand.The patient tolerated the procedure well and had significant improvement in the blood flow to the hand.The patient was discharged the next day with scheduled dialysis.Approximately nine months post graft placement, the patient experienced a thrombosis of the vascular access and was hospitalized.Initially, there was some concern for steal syndrome due to some discomfort of the right hand, however, this was ruled out.Pain management evaluated the subject and provided a variety of unspecified injections which seemed to improve symptoms and neurology gave approval to utilize the right arm for additional access placement.Therefore, the study conduit was abandoned and a right upper arm arteriovenous graft procedure was performed placing a new 4mm to 7mm acuseal graft.There was excellent pulsatility and thrill.Conclusion: the investigation can be confirmed for a leak at the graft.It can also be confirmed that the patient had an infection in the area of the graft however the relationship to the graft itself is unknown.Per the reported clinical trial results, the graft was flushed with heparin.Per ifu, "exposure to solutions may result in loss of graft's hydrophobic properties.Loss of the hydrophobic barrier may result in graft wall leakage." therefore, the integrity of the graft could have been compromised.However, the definitive root cause is unknown.Labeling review: the current instruction for use (ifu) states: warnings: aggressive and/or excessive graft manipulation when tunneling, or placement within a too tight or too small tunnel, may lead to separation of the spiral beading and/or graft breakage.Avoid repeated or excessive clamping at the same location on the graft.If clamping is necessary, use only atraumatic or appropriate vascular smooth jawed clamps to avoid damage to the graft wall.Exposure to solutions (e.G., alcohol, oil, aqueous solutions, etc.) may result in loss of the graft¿s hydrophobic properties.Loss of the hydrophobic barrier may result in graft wall leakage.Preclotting of this graft is unnecessary.Avoid excessive graft manipulation after exposure to blood or body fluids.Do not forcibly inject any solution through the lumen of the graft, or fill the graft with fluid prior to pulling it through the tunnel as loss of the graft¿s hydrophobic properties may occur.Loss of the hydrophobic barrier may result in graft wall leakage.

Event Description

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Brand Name

IMPRA VASCULAR GRAFT

Type of Device

EPTFE VASCULAR GRAFT

Manufacturer (Section D)

BARD PERIPHERAL VASCULAR, INC.

1625 w 3rd st.

tempe AZ 85281

Manufacturer (Section G)

BARD PERIPHERAL VASCULAR, INC.

1625 w 3rd st.

tempe AZ 85281

Manufacturer Contact

judith ludwig

1625 w 3rd st.

tempe, AZ 85281

4803032689

MDR Report Key

6329252

MDR Text Key

67371879

Report Number

2020394-2017-00067

Device Sequence Number

Product Code

DSY

UDI-Device Identifier

00801741021831

UDI-Public

(01)00801741021831(17)210425(10)VTAR0657

Combination Product (y/n)

Reporter Country Code

PMA/PMN Number

K004011

Number of Events Reported

Summary Report (Y/N)

Report Source

Manufacturer

Source Type

health professional,study,use

Reporter Occupation

Physician

Type of Report

Initial,Followup,Followup,Followup

Report Date

08/16/2017

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

04/25/2021

Device Model Number

40S06

Device Catalogue Number

40S06

Device Lot Number

VTAR0657

Was Device Available for Evaluation?

Is the Reporter a Health Professional?

Yes

Initial Date Manufacturer Received

01/18/2017

Initial Date FDA Received

02/14/2017

Supplement Dates Manufacturer Received

Not provided
Not provided
07/17/2017

Supplement Dates FDA Received

02/28/2017
04/21/2017
08/16/2017

Was Device Evaluated by Manufacturer?

Device Not Returned to Manufacturer

Date Device Manufactured

05/02/2016

Is the Device Single Use?

Yes

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage

Initial

Patient Sequence Number

Treatment

ADVAIR, GLYBURIDE, SYMBICORT, VENTOLIN HFA; CELEXA, ZYRTEC, VITAMIN D; FOLIC ACID WITH VITAMIN B, PROTONIX, ZYLOPRIM; HEPARIN, HYDRALAZINE, ZOFRAN; NEPHRO-VITE, ARANESP, TYLENOL 3, VANCOMYCIN; PARACETAMOL, LEVEMIR, COREG, IMDUR; PEPCID, MORPHINE, PHENERGAN, NITROGLYCERIN; XANAX, ASPIRIN, PHOSLO, VENOFER

Patient Outcome(s)

Hospitalization; Required Intervention;

Patient Age

56 YR

Patient Weight

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

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