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

Model Number	EV08181CD
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	12/01/2022
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: 11/2023).
Event or Problem Description
It was reported that during a stent placement procedure in right pulmonary artery, the stent allegedly dislodged from balloon.It was further reported that the stent was removed along with the entire stent delivery system.The procedure was completed by using another device.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 expandable biliary stent was returned for evaluation.The stent was still loaded on the balloon, and it appeared to be slightly bunched at the proximal end.No other anomalies were noted during the visual evaluation.Under microscopic examination, it was discovered that the stent had left an impression on the balloon at the proximal end, indicating a partial dislodging.Due to the nature of the complaint, no functional tests were performed.Therefore, the investigation confirmed the reported stent dislodgement, as under microscopic observation, stent impression marks were noted at the proximal end, showing the partial dislodgement of the stent.The investigation was also confirmed for the identified stent deformation, as it was noted to be bunched near the proximal end during the visual evaluation.A definitive root cause for the reported stent dislodgement 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.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 stent placement procedure in right pulmonary artery, the stent allegedly dislodged from balloon.It was further reported that the stent was removed along with the entire stent delivery system.The procedure was completed by using another device.There was no reported patient injury.

• Brand Name: VALEO BALLOON EXPANDABLE STENT GRAFT
• Common Device Name: BALLOON EXPANDABLE STENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 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: 16110661
• Report Number: 2020394-2022-01050
• Device Sequence Number: 20542744
• Product Code: FGE
• UDI-Device Identifier: 00801741000799
• UDI-Public: (01)00801741000799
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 02/10/2023

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: EV08181CD
• Device Catalogue Number: EV08181CD
• Device Lot Number: GFFX0850
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/13/2022
• Supplement Date Received by Manufacturer: 02/13/2023
• Initial Report FDA Received Date: 01/06/2023
• Supplement Report FDA Received Date: 02/21/2023
• 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 Age: 2 YR
• Patient Sex: Female
• Patient Weight: 12 KG
• Patient Race: Black Or African American