MAUDE Adverse Event Report: ANGIOMED GMBH & CO. MEDIZINTECHNIK KG FLUENCY PLUS VASCULAR STENT GRAFT

Catalog Number FVL14120

Device Problems Break (1069); Positioning Failure (1158); Fracture (1260); Misfire (2532)

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

Event Date 08/22/2023

Event Type  malfunction  

Event Description

It was reported that during a stent graft placement procedure, the catheter was allegedly ruptured during releasing.It was further reported that after having purged the catheter in the axis and in the y-cock, it was impossible to exercise the pull back to release the stent.Reportedly, the surgeon removed the system to do a new purged and after a second attempt to release the stent, the catheter allegedly ruptured under the action of the pull back.There was no reported patient injury.

Manufacturer Narrative

H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the fluency plus endovascular stent graft products that are cleared in the us.The pro code and 510 k number for the fluency plus endovascular stent graft products are identified in d2 and g4.H10: 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.H10: d4 (expiry date: 05/2026).H11: section a through f: the information provide 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 : device pending return.

Manufacturer Narrative

H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the fluency plus endovascular stent graft products that are cleared in the us.The pro code and 510 k number for the fluency plus endovascular stent graft products are identified in d2 and g4.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 graft delivery system was returned for evaluation.The outer sheath was fractured and the stent graft was found partially deployed which leads to confirmed results.Elongation at the fracture site indicates that high release force was present.The system was flushed, an 11f introducer / 0.035" guidewire were used for access, there was no calcification and vessel was straight, the device was placed in the straight section of the lumen during deployment attempts and the device didn't deploy at all.Based on evaluation of the device sample returned, the investigation is closed with confirmed results for break and partial deployment.Based on information available a definite root cause for the reported issue could not be determined.The intended use of the device to treat aneurysm represents off-label use.Labeling review: in reviewing the relevant labeling, it was found that the instructions for use sufficiently address the potential risks.Regarding tortuous anatomy the instructions for use states "prior to stent graft deployment in tortuous anatomy, 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 preparation of the device the ifu states: the instructions for use states: "prior to loading the delivery system over a guide wire, both ports must be flushed with sterile saline to eliminate any air bubbles that may be trapped in the inner catheter lumen and/or the stent graft lumen.Flushing these lumens will also facilitate stent graft deployment.A super stiff guide wire (0.035 in.) is advanced from a femoral artery puncture site.Use an introducer sheath for the implant procedure".The packaging pictograms indicate an introducer size of 10f and a 0.035" guidewire.The instructions for use states that "the safety and effectiveness of the device for use in the treatment of aneurysms and pseudoaneurysms have not been established".The intended use of the device to treat aneurysm represents off-label use.H10: d4 (expiration date: 05/2026), 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.H3 other text : see h10.

Event Description

It was reported that during a stent graft placement procedure, the catheter was allegedly ruptured during releasing.It was further reported that after having purged the catheter in the axis and in the y-cock, it was impossible to exercise the pull back to release the stent.Reportedly, the surgeon removed the system to do a new purged and after a second attempt to release the stent, the catheter allegedly ruptured under the action of the pull back.There was no reported patient injury.

Event Description

It was reported that during a stent graft placement procedure, the catheter was allegedly ruptured during releasing.It was further reported that after having purged the catheter in the axis and in the y-cock, it was impossible to exercise the pull back to release the stent.Reportedly, the surgeon removed the system to do a new purged and after a second attempt to release the stent, the catheter allegedly ruptured under the action of the pull back.There was no reported patient injury.

Manufacturer Narrative

H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the fluency plus endovascular stent graft products that are cleared in the us.The pro code and 510 k number for the fluency plus endovascular stent graft products are identified in d2 and g4.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 graft delivery system was returned for evaluation.The outer sheath was fractured and the stent graft was found partially deployed which leads to confirmed results.Elongation at the fracture site indicates that high release force was present.Based on the evaluation of the device sample returned, the investigation is closed with confirmed results for break and partial deployment.A definite root cause for the reported issue 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.Regarding tortuous anatomy the instructions for use states "prior to stent graft deployment in tortuous anatomy, 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 preparation of the device the instructions for use states: "prior to loading the delivery system over a guide wire, both ports must be flushed with sterile saline to eliminate any air bubbles that may be trapped in the inner catheter lumen and/or the stent graft lumen.Flushing these lumens will also facilitate stent graft deployment.A super stiff 0.035" guide wire is advanced from a femoral artery puncture site.Use an introducer sheath for the implant procedure".The packaging pictograms indicate an introducer size of 10f and a 0.035" guidewire.H10: d4 (expiration date: 05/2026), 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.

• Brand Name: FLUENCY PLUS VASCULAR STENT GRAFT
• Type of Device: VASCULAR STENT GRAFT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstr. 6; karlsruhe 76227 ; GM 76227
• 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: 17763321
• MDR Text Key: 323578783
• Report Number: 9681442-2023-00325
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00801741145377
• UDI-Public: (01)00801741145377
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P130029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: FVL14120
• Device Lot Number: ANHS2971
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2023
• 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