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

Model Number	EV08561CD
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number for the device was provided.The device history records are currently under review.The device has been returned for evaluation.The investigation is currently underway.
Event or Problem Description
It was reported that the balloon expandable stent allegedly dislodged from the balloon before exiting the introducer sheath while treating the right common/external iliac.The stent was successfully pulled out with the balloon catheter and another balloon expandable stent was used to complete the procedure.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: the lot number was provided, and the lot device history records have been reviewed.The 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 that has been reported for this corporate lot number to date.Investigation summary: one valeo balloon expandable stent delivery system and stent were returned for evaluation.The sample was returned bloody and the visual inspection noted that the stent had dislodged distally on the balloon.Additionally, the stent struts appeared bent and severely damaged.Functional testing was unable to be performed due to the condition of the device.One electronic photo was reviewed.The stent appears to have dislodged distally from the balloon.Based on the photo review, dislodgement of the stent can be confirmed.Therefore, the investigation is confirmed for dislodgement as the stent had dislodged from the balloon.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.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 the balloon expandable stent allegedly dislodged from the balloon before exiting the introducer sheath while treating the right common/external iliac.The stent was successfully pulled out with the balloon catheter and another balloon expandable stent was used to complete the procedure.There was no reported patient injury.

• Brand Name: VALEO BALLOON EXPANDABLE BILIARY STENT
• Common Device Name: BALLOON EXPANDABLE STENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 9670771
• Report Number: 2020394-2020-00863
• Device Sequence Number: 13548022
• Product Code: FGE
• UDI-Device Identifier: 00801741000850
• UDI-Public: (01)00801741000850
• 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): 04/07/2020

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: 06/05/2020
• Device Model Number: EV08561CD
• Device Catalogue Number: EV08561CD
• Device Lot Number: GFCS1395
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2020
• Initial Date Received by Manufacturer: 01/12/2020
• Supplement Date Received by Manufacturer: 04/06/2020
• Initial Report FDA Received Date: 02/05/2020
• Supplement Report FDA Received Date: 04/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 66