MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. VALEO BALLOON EXPANDABLE BILIARY 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	08/02/2019
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.(expiry date: 10/2020).
Event or Problem Description
It was reported that during treatment of the iliac artery, the stent graft allegedly dislodged from the delivery system while being inserted through the introducer sheath.It was further reported that another stent graft 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 device appeared to be bloody.The visual inspection noted that the stent was returned loose on the balloon and dislodged distally.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 dislodgement of the stent.The definitive root cause for the identified dislodged stent could not be determined based upon available information.It is unknown whether procedural issues involving the user's sheath contributed to the event.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.H10: d4(expiry date: 10/2020), g4.H11: h3, h6(results, conclusion).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 treatment of the iliac artery, the stent graft allegedly dislodged from the delivery system while being inserted through the introducer sheath.It was further reported that another stent graft was used to complete the procedure.There was no reported patient injury.

• Brand Name: VALEO BALLOON EXPANDABLE BILIARY STENT
• Common Device Name: BALLOON EXPANDABLE BILIARY STENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 8947125
• Report Number: 2020394-2019-03035
• Device Sequence Number: 2087610
• Product Code: FGE
• UDI-Device Identifier: 00801741000850
• UDI-Public: (01)00801741000850
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2020

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 Model Number: EV08561CD
• Device Catalogue Number: EV08561CD
• Device Lot Number: GFCW1425
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2019
• Initial Date Received by Manufacturer: 08/05/2019
• Supplement Date Received by Manufacturer: 02/10/2020
• Initial Report FDA Received Date: 08/29/2019
• Supplement Report FDA Received Date: 02/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR