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

Model Number FEM12060

Device Problems Break (1069); Difficult to Advance (2920)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/07/2023

Event Type  Injury  

Event Description

It was reported that during a stent graft placement procedure, the sheath was used to dilate and deploy the stent.It was further reported that a piece of deployment catheter was left allegedly inside the patient.Reportedly, the broken catheter segment was tried to retrieve using a snare but it allegedly floated down into the pulmonary artery and it caused arrhythmias thus the retrieval procedure had to be stopped.The current status of the patient is unknown.

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.(expiration date: 05/2025).Device pending return.

Event Description

It was reported that during a stent graft placement procedure, the sheath was used to dilate and deploy the stent.It was further reported that a piece of deployment catheter was left allegedly inside the patient.Furthermore, the catheter allegedly had difficulty in advancing thru the skin.Reportedly, the broken catheter segment was tried to retrieve using a snare but it allegedly floated down into the pulmonary artery and it caused arrhythmias thus the retrieval procedure had to be stopped.The current status of the patient is unknown.

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 with the completely deployed stent graft as part of the sample return.Even though it was reported that the stent graft was deployed in the patient, the stent graft was returned completely deployed for sample evaluation.The stent graft was found intact without any damages.The distal end of the outer sheath of the stent graft delivery system was found broken and missing which leads to confirmed results for catheter break.Images were not provided.It was reported that the device was used without an introducer sheath.In addition, it was reported that the distal end of delivery system may got bent due to difficulty in passing the device past the skin.Based on the provided information and the evaluation of the returned sample, the reported breakage of the distal end of the catheter is confirmed.It is reasonably suggested that the reported difficulties to enter the access site and the decision of the customer to not use an introducer sheath for access contributed to the reported event.However, a definite root cause for the event experienced by the customer could not be determined.Labeling review: the relevant labeling supplied with this product was reviewed.The instructions for use sufficiently address the potential risks.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." and "do not kink the delivery catheter or use excessive force during delivery to the target lesion." regarding required materials the instructions for use states that the following accessories should be used: "0.035" (0.889 mm) guidewire with a length at least twice as long as the endovascular system (.), introducer sheath with appropriate inner diameter.The packaging pictograms indicate the use of a 10f introducer.The instructions for use further state: "pre-dilate the lesion and confirm that the stenosed lumen can be dilated to the desired diameter." h10: b5, d4 (expiration date: 05/2025), g3, h6 (device).H11: h6 (method, result, conclusion).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.H3 other text : see h10.

• 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: 16483364
• MDR Text Key: 310678315
• Report Number: 2020394-2023-00133
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 04049519008646
• UDI-Public: (01)04049519008646
• 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: 03/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FEM12060
• Device Catalogue Number: FEM12060
• Device Lot Number: ANGS0739
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/16/2023
• 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