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

Catalog Number UNK FLUENCYPLUS ENDO STNT GRFT

Device Problems Break (1069); Activation Failure (3270)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/03/2022

Event Type  malfunction  

Event Description

It was reported that during a stent graft placement procedure, the stent allegedly failed to expand.The distal end remained covered until the rest of the stent deployed, at which point it was stuck.It was further reported that the tip of the delivery system allegedly broken.There was no reported patient injury.

Manufacturer Narrative

As the lot number for the device was not provided, a review of the device history records could not be performed.The return of the sample is pending.However, images were provided for review.The investigation of the reported event is currently underway.

Event Description

It was reported that during a stent graft placement procedure, the stent allegedly failed to expand.The distal end remained covered until the rest of the stent deployed, at which point it was stuck.It was further reported that the tip of the delivery system allegedly broken.There was no reported patient injury.

Manufacturer Narrative

H10: the fda rn number for the mdr 9681442-2022-00253 was inadvertently submitted as (b)(4).The correct fda rn number was (b)(4).H10: medical device catalog # was updated as unk fluencyplus endo stnt grft due to system limitations.The correct medical device catalog # was unk fluencyplus endovasc stnt grft.H10: manufacturing review: a manufacturing and inspection review of this product was not performed as the lot number was not provided.Investigation summary: a physical sample was not returned.A series of images were sent showing a stent graft being deployed overlapping with another stent.The distal end of the stent graft is not expanding as it appears that it is constricted by the marker band of the outer sheath while the rest of the stent graft is being deployed.In the final image the completely deployed stent graft can be seen.Based on this it can be reasonably assumed that the tip of the delivery system broke off and potentially remains in the patient.Based on the pictures provided, a failure to expand and break can be considered as reasonable failure modes.A definitive root cause could not be determined based upon the available information.Labeling review: in reviewing the relevant labeling, it was found that the instructions for use sufficiently address the potential risks.The instructions for use state: '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 state that 'prior to loading the endovascular 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 state: '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 increased deployment forces and possible endovascular system failure.' 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.' h10: g3.H11: d1, d2, d3, d4 (medical device catalog), h6 (method, result, conclusion).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.H3 other text : device not returned.

• 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: 15320495
• MDR Text Key: 303331913
• Report Number: 9681442-2022-00253
• Device Sequence Number: 1
• Product Code: PFV
• 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
• Report Date: 10/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK FLUENCYPLUS ENDO STNT GRFT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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