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

Model Number	EV08261CD
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.Expiry date (12/2021).
Event or Problem Description
It was reported that during a procedure, the stent was came off before balloon deployed.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one valeo balloon expandable stent delivery system and stent were returned for evaluation.The device appeared to be bloody.During visual inspection noted that the stent was returned half way off of the balloon.The balloon was examined under magnification and crimp marks were visible on the balloon.Functional testing was unable to be performed due to the condition of the device.Therefore, the investigation is confirmed for the dislodgement of the stent.The definitive root cause for the reported dislodgement issue of the stent could not be determined based upon available information.Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.H10: d4 (expiry date: 12/2021).H11:section a through f - the information provided by bd 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 bd.
Event or Problem Description
It was reported that during a procedure, the stent was came off before balloon deployed.There was no reported patient injury.

• Brand Name: VALEO BALLOON EXPANDABLE
• Common Device Name: BALLOON EXPANDABLE BILIARY STENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 10910217
• Report Number: 2020394-2020-20619
• Device Sequence Number: 19641053
• Product Code: FGE
• UDI-Device Identifier: 00801741000812
• UDI-Public: (01)00801741000812
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2021

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 Model Number: EV08261CD
• Device Catalogue Number: EV08261CD
• Device Lot Number: GFDY1411
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2020
• Initial Date Received by Manufacturer: 11/02/2020
• Supplement Date Received by Manufacturer: 04/30/2021
• Initial Report FDA Received Date: 11/26/2020
• Supplement Report FDA Received Date: 05/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other