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

Catalog Number	EV06181CD
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/10/2017
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 facility rep stated that the device was available for evaluation.A sample return kit was sent to the facility and is pending return.The results of the anticipated device evaluation will be provided upon completion of the event investigation.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 deployment of a balloon expandable stent in to the left pulmonary artery, it was alleged that the stent prematurely dislodged at the hemostasis valve of the sheath.Reportedly, another balloon expandable stent was used to complete the procedure.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: the device history records were 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.Visual/microscopic inspection: the balloon size for this product is printed on the balloon hub of the catheter and identified the returned sample as an 6mm x 18mm balloon.The stent was dislodged proximally; the stent was found to be dislodged up the device catheter shaft, and was able to move freely, therefore a measurement of where the stent was dislodged to could not be accurately taken.The balloon was examined under magnification (32x) and stent crimp marks were visible on the balloon.This indicates that the stent was crimped on the appropriate balloon location during the manufacturing process.No other anomalies were noted.Functional/performance evaluation:functional testing could not be performed as the stent was loose on the device.Medical records review: medical records were not provided; therefore, a review could not be performed.Image/photo review: images/photos were not provided; therefore, a review could not be performed.Conclusion: the device was returned.The device was examined under magnification, and the stent was found to have been dislodged proximally up the catheter, confirming the investigation for reported stent dislodgement.The definitive root cause for the dislodgement could not be determined based upon the available information.It is unknown if procedural issues contributed to the reported event.Labeling review: the current ifu (instructions for use) states: warnings: should unusual resistance be felt at any time during the insertion process, do not force passage.If resistance occurs during movement through the sheath/guiding catheter, the stent/catheter should be withdrawn carefully.During implantation, if resistance occurs after the stent has exited the sheath/guiding catheter or if the stent cannot be delivered to the target location, attempts to retract the stent/catheter into the sheath/guiding catheter may result in dislodgement and embolization of the stent.The stent/catheter/sheath/guiding catheter should be removed as a single unit.Precautions: inspect the valeo biliary stent and delivery system prior to use to verify that the stent has not been damaged during shipment or handling and that the device dimensions are suitable for the specific procedure.Do not attempt to remove or adjust the stent on the delivery system.Stent/delivery system preparation: remove the stent/delivery system from its packaging [and remove the transport mandrel and balloon sheath from the distal end of the catheter if present].Inspect the stent for adherence to the balloon and centered placement in relation to the balloon marker bands.Do not reposition the stent or hand crimp.(b)(4).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 deployment of a balloon expandable stent in to the left pulmonary artery, it was alleged that the stent prematurely dislodged at the hemostasis valve of the sheath.Reportedly, another balloon expandable stent was used to complete the procedure.There was no reported patient injury.

• Brand Name: VALEO BALLOON EXPANDABLE STENT
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 6461267
• Report Number: 2020394-2017-00308
• Device Sequence Number: 16262449
• Product Code: FGE
• UDI-Device Identifier: 00801741000652
• UDI-Public: (01)00801741000652(17)181222(10)GFAY3092
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2017

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: 12/22/2018
• Device Catalogue Number: EV06181CD
• Device Lot Number: GFAY3092
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/13/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/05/2017
• Supplement Report FDA Received Date: 05/31/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 14 YR