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

Catalog Number FEM14080

Device Problems Break (1069); Misfire (2532); Detachment of Device or Device Component (2907)

Patient Problem Embolism/Embolus (4438)

Event Date 08/21/2023

Event Type  Injury  

Manufacturer Narrative

H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.H10: d4 (expiry date: 02/2026).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 Description

It was reported that during a stent graft placement procedure in the subclavian vein, the distal end of the stent did not fully deploy and was stuck.It was further reported that a three millimeter balloon was used to inflate the distal tip of the stent to fully release the stent from the catheter and was successful.Furthermore, after post stent angiograms, the health care personnel noticed that there might be the radiopaque ring possibly may have been dislodged and migrated to the pulmonary artery.Reportedly, the health care personnel mentioned that the ring had embolized within the pulmonary artery.The current status of the patient is unknown.

Event Description

It was reported that during a stent graft placement procedure in the subclavian vein, the distal end of the stent did not fully deploy and was stuck.It was further reported that a three millimeter balloon was used to inflate the distal tip of the stent to fully release the stent from the catheter and was successful.Furthermore, after post stent angiograms, the health care personnel noticed that there might be the radiopaque ring possibly may have been dislodged and migrated to the pulmonary artery.Reportedly, the health care personnel mentioned that the ring had embolized within the pulmonary artery.The current status of the patient is unknown.

Manufacturer Narrative

Manufacturing review: based on the information available it is not reasonably suggested that a manufacturing process may have caused or contributed to the reported issue.However, the lot history records of this lot were reviewed with special attention to the manufacturing and inspection of this product and the product was found to have met the specification prior to shipment.Investigation summary: the stent delivery system was returned for evaluation.The delivery mechanism was fully activated; the stent was completely deployed and missing, as it was placed in the patient.The distal part of the outer catheter including the radiopaque marker band was missing which leads to confirmed result for sheath break and detachment.Based on the provided information and the evaluation of the returned sample, the investigation is closed with confirmed results for break and detachment.A definite root cause for the reported event could not be determined.Labeling review: relevant labeling for this product was reviewed.The instruction for use 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 preparation of the device the instruction for use states: "prior to loading the vascular system over a guide wire, both ports must be flushed with sterile saline (.).Flushing these lumens will also facilitate stent graft deployment".Regarding the anatomy of the placement site the instruction for use states: "prior to stent graft deployment (.), ensure that the proximal stent graft end is positioned in a straight section of the lumen to reduce the risk of increased deployment forces and possible failure to deploy".Regarding accessories the instruction for use states: "prepare a stiff 0.035" guidewire per its instructions for use and advance the guidewire under fluoroscopy to the target location.The use of an appropriately sized introducer sheath is recommended".The packaging pictograms indicate an introducer size of 10f and a 0.035" guidewire.With regards to stent placement, the instruction for use states "post dilate the stent graft with an angioplasty balloon sized appropriately as to ensure complete wall apposition to the reference vessel".The instruction for use also mentions detachment of device parts as a potential complication.D4 (expiry date: 02/2026).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.

Manufacturer Narrative

H10: manufacturing review: the lot history records of this lot were reviewed with special attention to the manufacturing and inspection of this product and the product was found to have met the specification prior to shipment.Based on the information available it is not reasonably suggested that a manufacturing process may have caused or contributed to the reported issue.Investigation summary: the stent delivery system was returned for evaluation.The delivery mechanism was fully activated; the stent was completely deployed and missing, as it was placed in the patient.The distal part of the outer catheter including the radiopaque marker band was missing which leads to confirmed result for sheath break and detachment.Based on the provided information and the evaluation of the returned sample, the investigation is closed with confirmed results for break and detachment.A definite root cause for the reported event could not be determined.Labeling review: relevant labeling for this product was reviewed.The instructions for use 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 preparation of the device the instructions for use states: "prior to loading the vascular system over a guide wire, both ports must be flushed with sterile saline.Flushing these lumens will also facilitate stent graft deployment".Regarding the anatomy of the placement site the instructions for use states: "prior to stent graft deployment, ensure that the proximal stent graft end is positioned in a straight section of the lumen to reduce the risk of increased deployment forces and possible failure to deploy".Regarding accessories the instructions for use states: "prepare a stiff 0.035" guidewire per its instructions for use and advance the guidewire under fluoroscopy to the target location.The use of an appropriately sized introducer sheath is recommended".The packaging pictograms indicate an introducer size of 10f and a 0.035" guidewire.With regards to stent placement, the instructions for use states "post dilate the stent graft with an angioplasty balloon sized appropriately as to ensure complete wall apposition to the reference vessel".The instructions for use also mentions detachment of device parts as a potential complication.H10: d4 (expiration date: 02/2026), g3.H11: section a through f ¿ the information provided by bd represents all 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 Description

It was reported that during a stent graft placement procedure in the subclavian vein for a thrombectomy procedure, the distal end of the stent allegedly did not fully deploy and became stuck in the catheter.It was further reported that a three millimeter balloon was used to inflate the distal tip of the stent to fully release the stent graft from the catheter and was successful.Furthermore, after post stent angiograms, the health care personnel noticed that there might be the radiopaque ring possibly may have been dislodged and migrated to the pulmonary artery.Reportedly, the health care personnel mentioned that the ring had embolized within the pulmonary artery.The patient is reportedly asymptomatic.

• 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; wachhausstr. 6; karlsruhe 76227 ; GM 76227
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 17796834
• MDR Text Key: 324004196
• Report Number: 2020394-2023-00719
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 04049519008707
• UDI-Public: (01)04049519008707
• 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: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/14/2023

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 Catalogue Number: FEM14080
• Device Lot Number: ANHP2329
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/28/2023
• Initial Date FDA Received: 09/22/2023
• Supplement Dates Manufacturer Received: 09/26/2023; 10/16/2023
• Supplement Dates FDA Received: 09/28/2023; 10/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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): Required Intervention