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

Model Number	EV08361CD
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history records will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.H10: d4 (expiry date: 09/2024).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.H3: device not returned.
Event or Problem Description
It was reported that during a stent placement procedure in the iliac common via common femoral access, the stent allegedly fell off in patient after exiting sheath.It was further reported that the snare was used to remove the dislodged component.There was no reported patient injury.
Event or Problem Description
It was reported that during a stent placement procedure in the iliac common via common femoral access, the stent allegedly fell off in patient after exiting sheath.It was further reported that the snare was used to remove the dislodged component.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: the physical device was not returned for evaluation.One electronic photo was reviewed.The photo shows a stent within a biohazard pack in which the stent is noted to have detached from the balloon catheter and the stent noted to be severely deformed or crumbled.No objective evidence of stent dislodgement could be observed based on the submitted photo.The photo also has the label of the device on which the product details can be verified with the reported event.As the submitted photo shows, the stent was noted to be detached from the catheter and no other objective evidence for the dislodgement could be noted due to the device's condition.The stent was also noted to be severely damaged and crumbled.Hence, the investigation was confirmed for the identified stent deformation.However, the reported stent dislodgment remains inconclusive.A definitive root cause for the reported stent dislodgment and identified stent deformation could not be determined based upon the provided information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: d4 (expiry date: 09/2024), g3, h6 (device, method).H11: h6 (result).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.

• 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 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: 17206878
• Report Number: 2020394-2023-00454
• Device Sequence Number: 6592167
• Product Code: FGE
• UDI-Device Identifier: 00801741000836
• UDI-Public: (01)00801741000836
• 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: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2023

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: EV08361CD
• Device Catalogue Number: EV08361CD
• Device Lot Number: GFGV1230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/01/2023
• Supplement Date Received by Manufacturer: 08/24/2023
• Initial Report FDA Received Date: 06/27/2023
• Supplement Report FDA Received Date: 08/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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