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

Model Number	EV07182CD
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history record 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.(expiry date: 09/2021).
Event or Problem Description
It was reported that prior to an angioplasty procedure through femoral artery to iliac artery stenosis the stent allegedly detached.It was further reported that the device allegedly broken.There was no reported patient contact.
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: the device was not returned for evaluation, two photos were provided for review.The first photo shows part of a catheter, the device was bloody and no kinks were noted.The stent got dislodged and deformed, second photo shows the label, lot number and catalog number were verified.Therefore based on the photos reviewed, the reported stent dislodgement and material deformation issue can be confirmed.A definitive root cause for the reported stent dislodgement and material deformation issue 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: d4 (expiry date: 09/2021).H11: section a through f ¿ the information provide 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 or Problem Description
It was reported that prior to an angioplasty procedure through femoral artery to iliac artery stenosis the stent allegedly dislodged.It was further reported that the device allegedly deformed.There was no patient contact.

• Brand Name: VALEO BALLOON EXPANDABLE BILIARY STENT
• Common Device Name: BALLOON EXPANDABLE VASCULAR COVERED STENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 11385127
• Report Number: 2020394-2021-00359
• Device Sequence Number: 4125982
• Product Code: FGE
• UDI-Device Identifier: 00801741000720
• UDI-Public: (01)00801741000720
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2021

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: EV07182CD
• Device Catalogue Number: EV07182CD
• Device Lot Number: GFDV3506
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/01/2021
• Supplement Date Received by Manufacturer: 04/01/2021
• Initial Report FDA Received Date: 02/26/2021
• Supplement Report FDA Received Date: 04/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other