MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. BARD JAVID CAROTID BYPASS SHUNT; CAROTID SHUNT

Catalog Number 007714

Device Problem Device Slipped (1584)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/04/2018

Event Type  malfunction  

Manufacturer Narrative

No medical records and no medical images were provided to the manufacturer.The lot number for the device was provided.The device history records are currently under review.The device was 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 a carotid bypass procedure, the smaller end of a tapered carotid shunt allegedly slipped out of the carotid artery multiple times.Reportedly, another shunt was used to complete the procedure.There was no reported patient injury.

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 complaint reported to date for this lot number and failure mode.Investigation summary: the device was returned.One photo was provided for review.Medical records were not provided.The evaluation of the returned device found all measurements to meet the required specifications.Therefore, the investigation is inconclusive for slippage of device as the procedure and patient factors could not be replicated.Per the reported event details, the small side of the taper was the side that continually came out of the artery during the procedure.Per the instructions for use (ifu), "when there is an incompatibility between the stabilizing technique, the artery and the shunt, slippage can occur.In order to avoid slippage and/or vessel damage or disruption when the clamp technique is utilized, users should ensure that the clamps they employ are compatible in size and design with the particular shunt they intend to use." therefore, the shunt size and or clamp technique could have caused or contributed to the slippage of the device.However, the definitive root cause is unknown.It is unknown whether patient and/or procedural issues contributed to the event.Labeling review: the current ifu pk4313200 rev 1 in this lot prescribed the proper method of implantation for this device to prevent undue injury to the patient and damage to the product.Reference ifu pk4313200 rev 1 directions for use how supplied/stored: bard® carotid bypass shunts are supplied sterile, unless package is damaged or opened.Single use.Do not resterilize.Bard® carotid bypass shunts are single-pouched and are supplied multiple pouches per box.Important: there are various techniques used in placing and affixing carotid bypass shunts.These shunts should be used only by qualified physicians thoroughly familiar with endarterectomy and patch-graft angioplasty techniques.Carotid bypass shunts are influenced by three significant factors: 1.The size, configuration and disease state of the artery.2.The design and dimensions of the shunt.3.The stabilization technique to hold the shunt in place.Stabilization can be accomplished by many techniques, including vessel loops, umbilical-type tapes, heavy ligatures, tourniquets, or surgical clamps.Surgical clamps should be appropriate in size and design for the shunt chosen.Warning: when there is an incompatibility between the stabilizing technique, the artery and the shunt, slippage can occur.In order to avoid slippage and/or vessel damage or disruption when the clamp technique is utilized, users should ensure that the clamps they employ are compatible in size and design with the particular shunt they intend to use.Suggested insertion techniques: non t-shaped shunts the carotid arteries should be isolated, tourniquet loops placed, and the arterial incision made.The proper size shunt must be chosen, determined at the time of surgery, based on the surgeon¿s experience and training.Forcing a shunt that is too large into an artery may cause vessel disruption.Insert the shunt into the artery.Care should be taken not to dislodge plaque, clot, or to raise intimal flaps.The bypass shunt is held in place by tension on the tourniquet loops.The endarterectomy is then performed.When the endarterectomy is completed, using standard cardiovascular techniques, which may include patch-graft angioplasty, the shunt is removed and the incision is closed.H11:section a through f - 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 a carotid bypass procedure, the smaller end of a tapered carotid shunt allegedly slipped out of the carotid artery multiple times.Reportedly, another shunt was used to complete the procedure.There was no reported patient injury.

• Brand Name: BARD JAVID CAROTID BYPASS SHUNT
• Type of Device: CAROTID SHUNT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 7740314
• MDR Text Key: 115767617
• Report Number: 2020394-2018-01332
• Device Sequence Number: 1
• Product Code: DWF
• UDI-Device Identifier: 00801741090110
• UDI-Public: (01)00801741090110
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Catalogue Number: 007714
• Device Lot Number: HUAV0493
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2018
• Initial Date Manufacturer Received: 07/04/2018
• Initial Date FDA Received: 08/01/2018
• Supplement Dates Manufacturer Received: 10/11/2018
• Supplement Dates FDA Received: 10/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1