MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. VALEO BALLOON EXPANDABLE STENT; BILIARY STENT

Model Number	EV07261CD
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/06/2018
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that during deployment of a balloon expandable stent in the renal artery, it was alleged that the stent prematurely dislodged from the balloon but was able to be deployed at the treatment site.The procedure was concluded, and no further treatment was provided.There was no reported patient injury.The patient was reported to be doing well post procedure.
Additional 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.This is the only complaint reported to date for this lot number and failure mode.The device was returned for evaluation.A visual inspection found the stent to have completely detached from the delivery system.The stent was returned stuck in the user's introducer sheath and was unable to be removed.Therefore, the investigation is confirmed for the reported detached stent.The definitive root cause for the identified detachment could not be determined based upon the available information.It is unknown if procedural issues contributed to the reported event.However, per the reported event details, the user was attempting to deploy the stent in the renal artery.Per the current instructions for use, the device is indicated for use in the palliation of malignant strictures in the biliary tree.Therefore, a letter will be sent to the facility as off-label issues were identified (e.G.Attempting to deploy a biliary-indicated device in the vascular system).The current instructions for use (ifu) states: device description: the stent is a permanently implanted device used to maintain patency of a major bile duct obstructed by tissue of an impinging tumor.Indications: the valeo balloon expandable biliary stent is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.Warnings: the safety and effectiveness of this device for use in the vascular system have not been established.(b)(4).
Event or Problem Description
It was reported that during deployment of a balloon expandable stent in the renal artery, it was alleged that the stent prematurely dislodged and subsequently got stuck inside the sheath.Reportedly, the health care provider removed the sheath, with the detached stent, and guidewire from the patient as one unit.Using the same access site, a new wire, sheath, and valeo stent was used to complete the procedure.There was no reported patient injury.The patient was reported to be doing well post procedure.

• Brand Name: VALEO BALLOON EXPANDABLE STENT
• Common Device Name: BILIARY STENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 7317462
• Report Number: 2020394-2018-00197
• Device Sequence Number: 1317052
• Product Code: FGE
• UDI-Device Identifier: 00801741000737
• UDI-Public: (01)00801741000737
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K052132
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/22/2018
• Device Model Number: EV07261CD
• Device Catalogue Number: EV07261CD
• Device Lot Number: GFAY3083
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2018
• Initial Date Received by Manufacturer: 02/07/2018
• Supplement Date Received by Manufacturer: 04/09/2018
• Initial Report FDA Received Date: 03/06/2018
• Supplement Report FDA Received Date: 04/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 89 YR