MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. FLUENCY PLUS ENDOVASCULAR STENT GRAFT

Model Number FEM14060

Device Problems Migration or Expulsion of Device (1395); Detachment of Device or Device Component (2907); Activation Failure (3270)

Patient Problem Embolism (1829)

Event Date 08/12/2019

Event Type  Injury  

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 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.Medical device - expiry date 11/2021.

Event Description

It was reported that during a stent graft placement procedure in a dissection of the right iliac vein, the radiopaque marker allegedly disengaged and looped around another marker preventing the distal end of the stent graft to expand.It was further reported that a balloon was loaded over the guidewire and used to dislodge the marker and enable the stent graft to expand.However, the stent graft was allegedly placed slightly further than anticipated and the radiopaque marker embolized to the pulmonary artery.The marker was not removed as it was not deemed a health hazard to the patient.Additionally, a second stent graft was placed to cover the entire area of the dissection.Further, a pta balloon was used to post dilate the area.The patient was reportedly stable post procedure.

• Brand Name: FLUENCY PLUS ENDOVASCULAR STENT GRAFT
• Type of Device: ENDOVASCULAR STENT GRAFT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• Manufacturer Contact: judith ludwig ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 8975784
• MDR Text Key: 156934005
• Report Number: 2020394-2019-03165
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 04049519008691
• UDI-Public: (01)04049519008691
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FEM14060
• Device Catalogue Number: FEM14060
• Device Lot Number: ANCY0420
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/13/2019
• Initial Date FDA Received: 09/09/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/03/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 38 YR