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

Model Number 40S06

Device Problem Occlusion Within Device (1423)

Patient Problems Hematoma (1884); Thrombus (2101)

Event Date 06/28/2017

Event Type  Injury  

Manufacturer Narrative

Manufacturing review: as the lot number for the device was not provided, a manufacturing review could not be performed.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.Medical records review: as medical records were not provided, a review could not be performed.Clinical trial results: the patient had a study conduit successfully placed in the left upper arm.Approximately 54 day post conduit placement, the patient experienced thrombosis of the vascular device and the patent was admitted to the hospital.Three attempts were made to access the conduit; however, clots were identified at each location.A bedside ultrasound was performed by the vascular access physician which revealed a hematoma at each access point.The recommendation was made to attempt access above the region of the conduit, and access was then successfully obtained.Hemodialysis then occurred without any complications.One day post hospital stay, the event was considered resolved and the patient was discharged from the hospital to follow up with the vascular access clinic.Image/photo review: as medical images were not provided, a review could not be performed.Conclusion: the device was not returned for evaluation.Images and medical records were not provided for review.Therefore, the investigation is inconclusive for the alleged occlusion 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: precautions: when suturing, avoid excessive tension on the suture line, inappropriate suture spacing and bites, and gaps between the graft and host vessel.Failure to follow correct suturing techniques may result in suture hole elongation, suture pull-out, anastomotic bleeding and/or disruption.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 54 days post study conduit placement, the subject experienced thrombosis of the study conduit.The subject was hospitalized and three separate attempts were made to access the conduit for dialysis; however, clot was identified at each access location.An ultrasound demonstrated a hematoma at each attempted access site.Access was finally obtained above the region of the conduit and hemodialysis occurred without complications.The subject was discharged the following day from the hospital and was to follow-up with the vascular access clinic.

• 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: 6789044
• MDR Text Key: 82520393
• Report Number: 2020394-2017-00952
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00801741021831
• UDI-Public: (01)00801741021831
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K004011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2017
• 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: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: COCODAMOL, PARACETAMOL; FLUOXETINE, FUROSEMIDE,AMLODIPINE, ATENOLOL
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 59 YR
• Patient Weight: 102