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

Model Number F7007TWS

Device Problem Torn Material (3024)

Patient Problem No Patient Involvement (2645)

Event Date 06/07/2017

Event Type  malfunction  

Manufacturer Narrative

No hospital/medical records or 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 been returned to the manufacturer for evaluation.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 that during preparation of a surgical graft, a tear in the graft occurred while removing the beading.A new surgical graft was prepped and implanted without incident.There was no reported patient injury.

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.The device history records showed that all process parameters were within specification and that lot of grafts passed all physical testing requirements.Visual/microscopic inspection: the graft was returned in two segments.Blue lines were identified on the segments of the graft.Tears along the beading track were observed on the first segment.No tears, suture marks, or holes were noted along the second segment.Dimensional evaluation: the total length of the two segments was measure to be 59.5 cm.However, it is unknown whether the graft portions had been trimmed and the remaining portion may have been discarded.Medical records review: as medical records were not provided, a review could not be performed.Image/photo review: as medical images were not provided, a review could not be performed.Conclusion: the device was returned for evaluation in two separate segments.The first segment was noted to have tears along the beading track.The second segment was noted not to have any tears along the length.Therefore, the investigation is confirmed for torn material.The root cause could not be determined based upon available information.It is unknown whether procedural factors contributed to the event.Labeling review: the current ifu (instructions for use) states: warnings do not remove the external spiral support (beading) from any centerflex¿ graft or endflex¿ graft.Attempts to remove the beading may damage the graft wall.If damage occurs, discard the graft precautions when removing the external spiral support (beading) of impra flex¿ grafts, the beading must be removed slowly and at a 90° angle to the graft.Rapid unwinding and/or removal at less than a 90° angle may result in graft damage.Do not use surgical blades or sharp, pointed instruments to remove the beading as this may damage the graft wall.If damage occurs, that segment of the graft should not be used.

Event Description

It was reported that during preparation of a surgical graft, a tear in the graft occurred while removing the beading.A new surgical graft was prepped and implanted without incident.There was no reported patient injury.

• 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
• 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: 6688585
• MDR Text Key: 79137338
• Report Number: 2020394-2017-00763
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00801741023262
• UDI-Public: (01)00801741023262
• Combination Product (y/n): N
• PMA/PMN Number: K004011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/29/2021
• Device Model Number: F7007TWS
• Device Catalogue Number: F7007TWS
• Device Lot Number: VTAU0915
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2016
• 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
• Patient Age: 78 YR
• Patient Weight: 59