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

Model Number	EV07561CD
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 and the evaluation is still pending.The investigation of the reported event is currently underway.Expiry date (03/2022).
Event or Problem Description
It was reported that during an upper extremity pta procedure in the radial artery, the stent allegedly dislodged off the balloon inside the sheath.The whole system was pulled out.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not performed as this is the only complaint reported for this lot number to date.Investigation summary: one valeo balloon expandable stent delivery system and stent along with one unknown sheath was returned for evaluation.The sample was returned bloody, the balloon was examined under magnification and it was noted that the visible stent crimp marks on the balloon.Additionally, the stent was damaged.Functional testing was not performed due to the reported nature of the failure.Therefore, the investigation is confirmed for dislodgement as the stent had dislodged from the balloon.A definitive root cause for the reported failure could not be determined based upon the provided information.Labeling review: a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, and unit label) showed that the product labeling is adequate.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 or Problem Description
It was reported that during an upper extremity pta procedure in the radial artery, the stent allegedly dislodged off the balloon inside the sheath.The whole system was pulled out.There was no reported patient injury.

• Brand Name: VALEO BALLOON EXPANDABLE
• Common Device Name: BALLOON EXPANDABLE STENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 10585343
• Report Number: 2020394-2020-05810
• Device Sequence Number: 14110242
• Product Code: FGE
• UDI-Device Identifier: 00801741000775
• UDI-Public: (01)00801741000775
• Combination Product (Y/N): N
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/28/2020

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: EV07561CD
• Device Catalogue Number: EV07561CD
• Device Lot Number: GFEP1502
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2020
• Initial Date Received by Manufacturer: 09/01/2020
• Supplement Date Received by Manufacturer: 11/16/2020
• Initial Report FDA Received Date: 09/25/2020
• Supplement Report FDA Received Date: 11/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1