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

Model Number	EV07181CD
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records and no medical images were provided to the manufacturer.The lot number for the device was provided.The device history records are currently under review.The device was returned to the manufacturer for evaluation.The investigation is currently under way.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 an angioplasty procedure in the left external iliac artery via right common femoral artery access site, the balloon expandable stent allegedly dislodged from the balloon.It was further reported that the catheter was removed and the stent came along with the balloon.Reportedly, another balloon expandable stent was used to perform the procedure.There was no reported patient injury.
Event or Problem Description
It was reported that during an angioplasty procedure in the left external iliac artery via right common femoral artery access site, the balloon expandable stent allegedly dislodged from the balloon.It was further reported that the catheter was removed and the stent came along with the balloon.Reportedly, another balloon expandable stent was used to perform the procedure.There was no reported patient injury.
Additional Manufacturer Narrative
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.This is the only complaint reported to date for this lot number and failure mode.Investigation summary: the device was returned for evaluation.A visual inspection found the stent dislodged proximally from the balloon on the catheter shaft of the delivery system.Stent crimp marks were noted on the balloon.Therefore, the investigation is confirmed for stent dislodgment.The definitive root cause for the identified dislodged 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.

• Brand Name: VALEO BALLOON EXPNDABLE VASCULAR COVERED 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: 7861910
• Report Number: 2020394-2018-01679
• Device Sequence Number: 11257800
• Product Code: FGE
• UDI-Device Identifier: 00801741000713
• UDI-Public: (01)00801741000713
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 12/03/2018

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 Model Number: EV07181CD
• Device Catalogue Number: EV07181CD
• Device Lot Number: GFAY0286
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2018
• Initial Date Received by Manufacturer: 08/15/2018
• Supplement Date Received by Manufacturer: 11/30/2018
• Initial Report FDA Received Date: 09/10/2018
• Supplement Report FDA Received Date: 12/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 97