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

Model Number	EV08181CD
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number for the device was provided.The device history records are currently under review.The device has been returned for evaluation.The investigation is currently underway.(expiry date 09/2021).
Event or Problem Description
It was reported that during a balloon expandable stent placement via right femoral vein access, the stent allegedly migrated of the balloon and began to bend after advancing into the introducer sheath.Reportedly, a new stent was used to complete the procedure.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: the device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process, and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing-related cause for this event.Investigation summary: the device was returned for evaluation.The device appeared to be bloody.The stent was noted to be loose on the balloon and dislodged proximally.The failure mode ¿2981 ¿ material twisted¿ is confirmed as the middle of the stent was noted to be bunched.No kinks were identified on the catheter as well as no anomalies to the luers and y-body.The balloon was examined under magnification and stent crimp marks were visible on the balloon.Therefore, based on the returned sample, the investigation is also confirmed for dislodgement of the stent.The definitive root cause for the identified dislodged and material twisted stent could not be determined based upon available information.It is unknown whether procedural issues involving the user's sheath contributed to the event.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.H10: g4 h11: b5, h3, h6(results, 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 or Problem Description
It was reported that during a balloon expandable stent placement via right femoral vein access, the stent allegedly migrated off the balloon and began to bend after advancing into the introducer sheath.Reportedly, a new stent was used to complete the procedure.There was no reported patient injury.

• 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: 9280655
• Report Number: 2020394-2019-04372
• Device Sequence Number: 16765137
• 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,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2020

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: EV08181CD
• Device Catalogue Number: EV08181CD
• Device Lot Number: GFDV0754
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2019
• Initial Date Received by Manufacturer: 10/09/2019
• Supplement Date Received by Manufacturer: 02/24/2020
• Initial Report FDA Received Date: 11/05/2019
• Supplement Report FDA Received Date: 02/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 7 MO
• Patient Weight: 9