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

Model Number	EV08181CD
Medical Device Problem Codes	Difficult to Insert (1316); Kinked (1339); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.The information provided by bard 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 bard.
Event or Problem Description
It was reported that during advancement of a balloon expandable stent through the hemostatic valve of an introducer sheath (other manufacturer), the stent had allegedly kinked and dislodged from the balloon; however, it remained on the catheter.Reportedly, the entire system was removed and the health care provider used another balloon expandable stent to complete the procedure.There was no reported patient injury.
Event or Problem Description
It was reported that during advancement of a balloon expandable stent through the hemostatic valve of an introducer sheath (other manufacturer), the stent had allegedly kinked and dislodged from the balloon; however, it remained on the catheter.Reportedly, the entire system was removed and the health care provider used another balloon expandable stent to complete the procedure.There was no reported patient injury.
Additional Manufacturer Narrative
As the lot number for the device was provided, a manufacturing review was performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.

• Brand Name: VALEO BALLOON EXPANDABLE STENT
• Common Device Name: BALLOON EXPANDABLE STENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 7438882
• Report Number: 2020394-2018-00403
• Device Sequence Number: 13717163
• Product Code: FGE
• UDI-Device Identifier: 00801741000799
• UDI-Public: (01)00801741000799
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 05/21/2018

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 Expiration Date: 12/06/2019
• Device Model Number: EV08181CD
• Device Catalogue Number: EV08181CD
• Device Lot Number: GFBY0935
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/23/2018
• Supplement Date Received by Manufacturer: 04/30/2018
• Initial Report FDA Received Date: 04/17/2018
• Supplement Report FDA Received Date: 05/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 10