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

Catalog Number FVL08120

Device Problems Fracture (1260); Misfire (2532); Activation Failure (3270)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/26/2023

Event Type  Injury  

Event Description

It was reported that during a stent graft placement procedure in bilateral iliac artery, the stent was allegedly released three/one.It was further reported that the withdrawal operation allegedly cannot be released.Reportedly, the stent was removed through incision.The current status of patient is unknown.

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 that are cleared in the us.The pro code and 510 k number for the fluency plus endovascular stent graft 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 device has not been returned to the manufacturer for evaluation.However, photos were provided for review.The investigation of the reported event is currently underway.H10: d4 (expiry date: 04/2024).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: the catalog number identified in section d4 has not been cleared in the us but is similar to the fluency plus endovascular stent graft that are cleared in the us.The pro code and 510 k number for the fluency plus endovascular stent graft 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 not returned for evaluation.However, photos of the delivery system were provided, showing the stent graft partially deployed and the blue outer sheath of the delivery system was fractured.The fracture of the delivery system catheter is considered to be an indication for increased resistance during the attempt to deploy the stent graft.The vessel was reported being tortuous and tracking of the guide wire and the delivery system was difficult.In addition, the lesion was reported not being predilated.Based on reported information and provided photos, the investigation is closed with confirmed results for partial deployment and sheath fracture.A definite root cause for the reported event could not be determined.Labeling review: relevant labeling supplied with this product was reviewed.The instructions for use was found to address the potential risks.Regarding preparation of the device the instructions for use states that "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.Continue until saline drips from the distal end of the delivery system".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: "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 9f and a 0.035" guidewire.Predilatation of the stenosis may be performed prior to stent graft deployment at the discretion of the physician." h10: d4 (expiration date: 04/2024), g3.H11: b5.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 : device not returned.

Event Description

It was reported that during a stent graft placement procedure in the bilateral iliac artery via the right femoral artery approach, the stent graft was allegedly partially deployed.It was further reported that the stent allegedly cannot be released during withdrawal operation.Reportedly, the stent was removed through incision.The procedure was completed using another device.The current status of the patient is unknown.

Event Description

It was reported that during a stent graft placement procedure in bilateral iliac artery via the right femoral artery approach, the stent was allegedly only released three/one.It was further reported that the stent allegedly cannot be released during withdrawal operation.Reportedly, the stent was removed through incision.The current status of patient is unknown.

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 that are cleared in the us.The pro code and 510 k number for the fluency plus endovascular stent graft 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 not returned for evaluation.However, photos of the delivery system were provided, showing the stent graft partially deployed and the blue outer sheath of the delivery system was fractured.The fracture of the delivery system catheter is considered to be an indication for increased resistance during the attempt to deploy the stent graft.The vessel was reported being tortuous and tracking of the guide wire and the delivery system was difficult.In addition, the lesion was reported not being predilated.Based on reported information and provided photos, the investigation is closed with confirmed results for partial deployment and sheath fracture.A definite root cause for the reported event could not be determined.Labeling review: relevant labeling supplied with this product was reviewed.The instruction for use was found to address the potential risks.Regarding preparation of the device the instruction for use states that "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.Continue until saline drips from the distal end of the delivery system".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: "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 9f and a 0.035" guidewire.Predilatation of the stenosis may be performed prior to stent graft deployment at the discretion of the physician." h10: b5, d4 (expiry date: 04/2024), g3.H11: h6 (device, 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 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: 18345223
• MDR Text Key: 330725605
• Report Number: 9681442-2023-00400
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 01/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: FVL08120
• Device Lot Number: ANFR2451
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/30/2024
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male