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

Catalog Number EV08262CD

Device Problems Difficult to Insert (1316); Device Dislodged or Dislocated (2923); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/28/2023

Event Type  malfunction  

Event Description

It was reported that during an angioplasty procedure in the external iliac artery via the common femoral artery, the stent allegedly got caught in valve of sheath when tried to advance.It was further reported that the stent was not very tight on the balloon either and slid off way too easy.The procedure was completed using another device.There was no reported patient injury.

Manufacturer Narrative

H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.However, a photo was provided for review.The investigation of the reported event is currently underway.H10: d4 (expiration date: 10/2024).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 other text : device not returned.

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: the physical device was not returned for evaluation.One photo was provided and reviewed.The photo shows the valeo balloon deflated and bloody.The stent is seen deformed and dislodged from the balloon.No other anomalies noted.Therefore, the investigation is confirmed for the reported stent dislodgement and identified stent deformation as the stent is seen deformed and dislodged from the balloon.However, the investigation is inconclusive for the reported sheath insertion difficulty as functional testing for the same could not be performed due to the condition of the device.A definitive root cause for the alleged sheath insertion difficulty, 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.H10: d4 (expiration date: 10/2024).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 other text : device not returned.

Event Description

It was reported that during an angioplasty procedure in the external iliac artery via the common femoral artery, the stent allegedly got caught in valve of sheath when tried to advance.It was further reported that the stent was not very tight on the balloon either and slid off way too easy.The procedure was completed using another device.There was no reported patient injury.

• Brand Name: VALEO
• Type of Device: BALLOON EXPANDABLE BILIARY 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: 17765296
• MDR Text Key: 324025505
• Report Number: 2020394-2023-00697
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 00801741000829
• UDI-Public: (01)00801741000829
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052132
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EV08262CD
• Device Lot Number: GFGW1495
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1