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

Model Number EV08561CD

Device Problems Difficult to Insert (1316); Device-Device Incompatibility (2919)

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

Event Date 05/11/2021

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was not provided, a review of the device history records could not be performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.

Event Description

It was reported that during the procedure, the stent allegedly had difficult to pass through the sheath.It was further reported that another device was used to complete the procedure.There was no reported patient injury.

Manufacturer Narrative

H10: the file was reassessed for reportability and determined to be no longer reportable.Since an initial mdr was submitted, therefore, the file will remain assessed as a malfunction.H10: manufacturing review: a manufacturing review was not requested as the lot number reported as unknown.Investigation summary: one valeo pta dilatation catheter has been received for the evaluation.On the visual evaluation, the device was noted bloody and the stent was bunched up, deformed and dislodged, the balloon was then examined under magnification and stent crimp marks were visible on the balloon.No kinks to the catheter, no other anomalies were noted to the sample.Therefore the investigation for the reported difficult to insert remains inconclusive as no functional testing performed due to the condition of the device returned for evaluation.A definitive root cause for the difficult to insert could not be determined based upon the provided information.Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.H10: g3.H11: h6 (device, method, result and conclusion).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 Description

It was reported that during the procedure, the stent allegedly had difficult to pass through the sheath.It was further reported that another device was used to complete the procedure.There was no reported patient injury.

• Brand Name: VALEO
• Type of Device: BALLOON EXPANDABLE STENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 11928863
• MDR Text Key: 254048343
• Report Number: 2020394-2021-01160
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 00801741000850
• UDI-Public: (01)00801741000850
• Combination Product (y/n): N
• PMA/PMN Number: K052132
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EV08561CD
• Device Catalogue Number: EV08561CD
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2021
• Date Manufacturer Received: 06/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other