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

Model Number	FEM08040
Medical Device Problem Codes	Break (1069); Fracture (1260); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
Date of Event	05/04/2018
Type of Reportable Event	Serious Injury
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 return of the device is pending.The investigation is currently underway.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 a right upper extremity fistulogram, angioplasty of venous outflow stenosis, management of pseudoaneurysm, and placement of stent; when deploying the stent graft a radiopaque marker allegedly detached and migrated through the patient's vein through the superior vena cava and into the lung (patient's left lower lobe pulmonary artery).It was further reported that the health care provider initially attempted to snare the segment unsuccessfully.Therefore, the segment was left in place as the risk for retrieval out weighted the benefits; so, no further radiopaque marker retrieval intervention was performed.Reportedly, another endovascular stent graft catheter was used to complete the procedure.The patient is reportedly doing well.
Additional Manufacturer Narrative
No medical records and no medical images were provided to the manufacturer, however, a photo was provided and is under review.The lot number for the device was provided.The device history records are currently under review.The return of the device is pending.The investigation is currently underway.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 a right upper extremity fistulogram, angioplasty of venous outflow stenosis, management of pseudoaneurysm, and placement of stent; when deploying the stent graft a radiopaque marker allegedly detached and migrated through the patient's vein through the superior vena cava and into the lung (patient's left lower lobe pulmonary artery).It was further reported that the health care provider initially attempted to snare the segment unsuccessfully.Therefore, the segment was left in place as the risk for retrieval out weighted the benefits; so, no further radiopaque marker retrieval intervention was performed.Reportedly, another endovascular stent graft catheter was used to complete the procedure.The patient is reportedly doing well.
Additional Manufacturer Narrative
Manufacturing review: the lot number was provided and the lot device history records have been reviewed.The 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 that has been reported for this corporate lot number to date.Investigation summary: based on the investigation of the provided image a radiopaque sheath marker detachment could not be confirmed.Due to poor resolution a detached radiopaque sheath marker could not be found on the image.The alleged detachment could not be re produced which led to an inconclusive evaluation result.The use of the product for pseudoaneurysm management represents an off label use of the device.However, based on the available information a definite root cause for the reported event could not be determined.Labeling review: in reviewing the relevant ifu for this product, the potential issue was found addressed.Regarding stent graft deployment the ifu states: 'if unusual resistance or high deployment force is encountered during stent graft deployment, abort the procedure, remove the delivery system and use an alternative device'.Regarding the anatomy of the placement site the ifu states: 'the safety and effectiveness of the device when placed across a tight bend (.) has not been evaluated.Prior to stent graft deployment, ensure that the proximal (inflow) stent graft end is positioned in a straight section of the lumen to reduce the risk of higher deployment forces and possible endovascular system failure' and 'do not kink the delivery catheter or use excessive force during delivery to the target lesion.' furthermore, the ifu states: 'examine the packaging and endovascular system to determine if there is any damage, defects or if the sterile barrier is compromised.Do not use the device if any of these conditions are observed.', and 'prior to loading the endovascular system over a guide wire, both ports must be flushed (.).Flushing these lumens will also facilitate stent graft deployment'.The ifu demands for 'introducer sheath with appropriate inner diameter'.The ifu further states: 'the safety and effectiveness of the device when placed across an aneurysm or a pseudoaneurysm has not been evaluated.'.
Event or Problem Description
It was reported that during a right upper extremity fistulogram, angioplasty of venous outflow stenosis, management of pseudoaneursym, and placement of stent; when deploying the stent graft a radiopaque marker allegedly detached and migrated through the patient's vein through the superior vena cava and into the lung (patient's left lower lobe pulmonary artery).It was further reported that the health care provider initially attempted to snare the segment unsuccessfully.Therefore, the segment was left in place as the risk for retrieval out weighted the benefits; so, no further radiopaque marker retrieval intervention was performed.Reportedly, another endovascular stent graft catheter was used to complete the procedure.The patient is reportedly doing well.

• Brand Name: FLUENCY PLUS ENDOVASCULAR STENT GRAFT
• Common Device Name: ENDOVASCULAR STENT GRAFT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 7559067
• Report Number: 2020394-2018-00774
• Device Sequence Number: 10815391
• Product Code: PFV
• UDI-Device Identifier: 04049519008486
• UDI-Public: (01)04049519008486
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P130029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Caregivers
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/18/2018

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
• Operator of Device: Health Professional
• Device Model Number: FEM08040
• Device Catalogue Number: FEM08040
• Device Lot Number: ANBW2753
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/04/2018
• Supplement Date Received by Manufacturer: 06/25/2018; 07/12/2018
• Initial Report FDA Received Date: 05/31/2018
• Supplement Report FDA Received Date: 06/25/2018; 07/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 85 YR