MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. IMPRA HIGH POROSITY GRAFTS; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

Catalog Number F7006TWS

Device Problems Material Separation (1562); Torn Material (3024)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The device history records were reviewed with special attention to the raw materials, subassemblies, manufacturing process and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Visual inspection & functional/performance evaluation: the device was not returned; therefore, no visual inspection or functional testing of the device was performed.Medical records review: medical records were not provided for review.Image/photo review: images/photos were not provided for review.Conclusion: the device was not provided for evaluation.Images were not provided for review.Therefore, the investigation was inconclusive for the alleged material separation of the beading and torn material as no objective evidence was provided to confirm any alleged deficiency with the graft.The root cause could not be determined based upon available information.It was 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.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/ beading removal, the beading on the eptfe graft was allegedly unraveled and torn material was identified.Reportedly, another graft was used to complete the procedure.There was no patient contact.

• Brand Name: IMPRA HIGH POROSITY GRAFTS
• Type of Device: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
• 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: 6592872
• MDR Text Key: 76054324
• Report Number: 2020394-2017-00517
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00801741023255
• UDI-Public: (01)00801741023255(17)210119(10)VTAN0522
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K983064
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/19/2021
• Device Catalogue Number: F7006TWS
• Device Lot Number: VTAN0522
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2016
• 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