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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); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Stenosis (2263)
Event Date 11/20/2017
Event Type  Injury  
Manufacturer Narrative
No device, no medical records, or no medical images were provided to the manufacturer.The lot number for the device was not provided; therefore, a review of the device history records could not be performed.The investigation of the reported event is currently underway.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, approximately 159 days post conduit implant, the subject experienced stenosis of vascular access which was moderate in intensity.The subject presented to their 6-month protocol visit with swelling.Duplex ultrasound did not visualize stenosis; however, stenosis was suspected.A fistulogram revealed venous anastomotic stenosis, which improved after balloon angioplasty.At the time of reporting, the event was unresolved.There was no reported patient injury.
 
Manufacturer Narrative
Manufacturing review: a complete manufacturing review could not be conducted for the investigation as the lot number is unknown.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: the current ifu (instructions for use) states: adverse reactions: potential complications which may occur with any surgical procedure involving a vascular prosthesis include, but are not limited to: disruption or tearing of the suture line, graft, and/or host vessel; suture hole bleeding; graft redundancy; thrombosis, embolic events, occlusion or stenosis; ultrafiltration; seroma formation; swelling of the implanted limb; formation of hematoma or pseudoaneurysm; infection; aneurysm/dilation; blood leakage; hemorrhage; steal syndrome; and/or skin erosion.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, approximately 159 days post conduit implant, the subject experienced stenosis of vascular access which was moderate in intensity.The subject presented to their 6-month protocol visit with swelling.Duplex ultrasound did not visualize stenosis; however, stenosis was suspected.A fistulogram revealed venous anastomotic stenosis, which improved after balloon angioplasty.At the time of reporting, the event was unresolved.There was no reported patient injury.It was reported through the results of a clinical trial, that at approximately six months and at ten months post conduit implant, angiograms demonstrated stenosis at the venous anastomosis, which improved after balloon angioplasty.It was further reported that at approximately 11 months post conduit implant, the subject withdrew consent and the event was considered unresolved.
 
Manufacturer Narrative
A complete manufacturing review could not be conducted for the investigation as the lot number is unknown.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: the current ifu (instructions for use) states: adverse reactions: potential complications which may occur with any surgical procedure involving a vascular prosthesis include, but are not limited to: disruption or tearing of the suture line, graft, and/or host vessel; suture hole bleeding; graft redundancy; thrombosis, embolic events, occlusion or stenosis; ultrafiltration; seroma formation; swelling of the implanted limb; formation of hematoma or pseudoaneurysm; infection; aneurysm/dilation; blood leakage; hemorrhage; steal syndrome; and/or skin erosion.
 
Event Description
It was reported through the results of a clinical trial, approximately 159 days post conduit implant, the subject experienced stenosis of vascular access which was moderate in intensity.The subject presented to their 6-month protocol visit with swelling.Duplex ultrasound did not visualize stenosis; however, stenosis was suspected.A fistulogram revealed venous anastomotic stenosis, which improved after balloon angioplasty.At the time of reporting, the event was unresolved.There was no reported patient injury.
 
Manufacturer Narrative
Manufacturing review: a complete manufacturing review could not be conducted for the investigation as the lot number is unknown.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: the current ifu (instructions for use) states: adverse reactions: potential complications which may occur with any surgical procedure involving a vascular prosthesis include, but are not limited to: disruption or tearing of the suture line, graft, and/or host vessel; suture hole bleeding; graft redundancy; thrombosis, embolic events, occlusion or stenosis; ultrafiltration; seroma formation; swelling of the implanted limb; formation of hematoma or pseudoaneurysm; infection; aneurysm/dilation; blood leakage; hemorrhage; steal syndrome; and/or skin erosion.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, approximately 159 days post conduit implant, the subject experienced stenosis of vascular access which was moderate in intensity.The subject presented to their 6-month protocol visit with swelling.Duplex ultrasound did not visualize stenosis; however, stenosis was suspected.A fistulogram revealed venous anastomotic stenosis, which improved after balloon angioplasty.At the time of reporting, the event was unresolved.There was no reported patient injury.It was reported through the results of a clinical trial, that at approximately six months and at ten months post conduit implant, angiograms demonstrated stenosis at the venous anastomosis, which improved after balloon angioplasty.It was further reported that at approximately 11 months post conduit implant, the subject withdrew consent and the event was considered unresolved.
 
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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 Key7208359
MDR Text Key97952265
Report Number2020394-2018-00013
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 health professional,study
Type of Report Initial,Followup,Followup,Followup
Report Date 08/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/19/2018
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 Received08/20/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
AMLODIPINE, FISH OIL, BREO,; AMLODIPINE, FISH OIL, BREO,; FISH OIL, BREO, INCRUSE, CALCIUM ACETATE; FISH OIL, BREO, INCRUSE, CALCIUM ACETATE; INCRUSE, CALCIUM ACETATE, LISINOPRIL,; INCRUSE, CALCIUM ACETATE, LISINOPRIL,; LISINOPRIL, LORATADINE, VENTOLIN, VITAMIN D3; LISINOPRIL, LORATADINE, VENTOLIN, VITAMIN D3; LORATADINE, VENTOLIN, VITAMIN D3,; LORATADINE, VENTOLIN, VITAMIN D3,; MULTIVITAMIN, ASPIRIN, ATORVASTATIN,; MULTIVITAMIN, ASPIRIN, ATORVASTATIN,; MULTIVITAMIN, ASPIRIN, ATORVASTATIN, AMLODIPINE; MULTIVITAMIN, ASPIRIN, ATORVASTATIN, AMLODIPINE
Patient Outcome(s) Required Intervention;
Patient Age41 YR
Patient Weight146
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