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

Catalog Number	EV08262CD
Medical Device Problem Codes	Difficult to Insert (1316); Device Dislodged or Dislocated (2923); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that prior to an angioplasty procedure in the common iliac artery via the contralateral femoral access, when the physician was going to pass the stent through the sheath, the stent allegedly dislodged and came off the balloon at the sheath valve.It was further reported that when attempted to put the stent back through the sheath, the stent allegedly crimped between the physician's finger and the sheath.The procedure was completed using another device.There was no patient contact.
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records will be performed.The return of the sample is pending.The investigation of the reported event is currently underway.Section a through f ¿ the information provided by bd represents all 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.Device pending return.
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 expandable biliary stent was returned for evaluation.On the visual evaluation, the stent was noted to be dislodged distal to the distal end of the balloon and crumbled.No other anomalies were noted, and no functional testing was performed due to the nature of the complaint and the condition of the device.As the return sample evaluation confirms, the stent was noted to be dislodged and crumbled during the visual examination and no functional testing was performed.The investigation is confirmed for the reported stent dislodgement and deformation issues.However, the investigation remains inconclusive for the reported sheath insertion failure issue.A definitive root cause for the reported stent dislodgement, deformation and sheath insertion failure issues could not be determined based upon the provided information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: d4 (expiration date: 07/2024).H11: section a through f ¿ the information provided by bd represents all 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 prior to an angioplasty procedure in the common iliac artery via the contralateral femoral access, when the physician was going to pass the stent through the sheath, the stent allegedly dislodged and came off the balloon at the sheath valve.It was further reported that when attempted to put the stent back through the sheath, the stent allegedly crimped between the physician's finger and the sheath.The procedure was completed using another device.There was no patient contact.

• Brand Name: VALEO
• Common Device Name: BALLOON EXPANDABLE BILIARY STENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe 85281
• Manufacturer (Section G): C.R. BARD, INC. (GFO); 289 bay road; queensbury 12804
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 19103022
• Report Number: 2020394-2024-00505
• Device Sequence Number: 7428062
• Product Code: FGE
• UDI-Device Identifier: 00801741000829
• UDI-Public: (01)00801741000829
• 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: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2024

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 Catalogue Number: EV08262CD
• Device Lot Number: GFGT1727
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/22/2024
• Supplement Date Received by Manufacturer: 05/02/2024
• Initial Report FDA Received Date: 04/14/2024
• Supplement Report FDA Received Date: 05/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown