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

Catalog Number EV10171CD

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

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

Event Date 05/11/2023

Event Type  malfunction  

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 been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.H10: d4 (expiration date: 02/2024).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 Description

It was reported that during a stent placement procedure, stent allegedly pushed back off the balloon.It was further reported that the stent was never able to pass through valve itself.The procedure was completed using another device.There was no reported patient injury.

Event Description

It was reported that during a stent placement procedure, stent allegedly pushed back off the balloon.It was further reported that the stent was never able to pass through valve itself.The procedure was completed using another device.There was no reported patient injury.

Manufacturer Narrative

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 pta dilatation catheter was returned for evaluation.The stent was noted to be loaded within the balloon, and no objective evidence of dislodgement was noted.No other anomalies were noted during the visual evaluation.On the functional testing, the guide wire lumen was flushed without any issue.An in-house guide wire was able to be inserted without any issue.Upon attempting to insert the catheter into the in-house sheath, it was unsuccessful, and a strong resistance was felt during insertion.Upon removal from the sheath, the stent was noted to be dislodged from the balloon.No other functional testing.As the stent was loaded within the balloon and there was no objective evidence of dislodgment during the visual evaluation of the returned device, and during the functional testing the balloon catheter was unable to insert into the sheath.Hence, the investigation was unconfirmed for the reported stent dislodgement; however, the investigation was confirmed for the reported sheath insertion difficulties.A definitive root cause for the reported sheath insertion difficulties and stent dislodgement 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.D4 (expiration date: 02/2024).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.

• Brand Name: VALEO
• Type of Device: 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: 17508825
• MDR Text Key: 320890805
• Report Number: 2020394-2023-00580
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 00801741000935
• UDI-Public: (01)00801741000935
• 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: 08/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EV10171CD
• Device Lot Number: GFGN1058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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