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

Catalog Number FVL14040

Device Problems Positioning Failure (1158); Fracture (1260); Material Invagination (1336)

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

Event Date 11/07/2021

Event Type  malfunction  

Event Description

It was reported that during a stent graft placement through the femoral artery, the stent allegedly failed to be deployed upon reaching the common iliac artery.Multiple attempts were made, however the stent did not get released.The device was removed and failed to get deployed even though the delivery sheath broke due to the excessive force applied.The procedure was completed using another device.There was no reported patient injury.

Manufacturer Narrative

The catalog number 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.As the lot number for the device was not provided, a review of the device history records could not be performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.

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 been returned to the manufacturer.The investigation of the reported event is currently underway.H10: d4 (expiry date: 08/2023), g3.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 placement procedure through the femoral artery, the stent allegedly did not get deployed upon reaching the common iliac artery.Multiple attempts were made however the stent did not get released.The device was removed and was tried to be deployed however the delivery sheath broke due to the excessive force applied but still the stent would not get deployed.The procedure was completed using another device.There was no reported patient injury.

Event Description

It was reported that during a stent placement procedure through puncture on the femoral artery, the stent allegedly did not get deployed upon reaching the common iliac artery.Multiple attempts were made however the stent did not get released.The device was removed and was tried to be deployed however the delivery sheath broke due to the excessive force applied but still the stent would not get deployed.The procedure was completed using another device.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 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: a review of manufacturing records was not performed, as additional complaints have not been reported for this lot.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 sample was returned to the manufacturer for evaluation.Based on the investigation performed in the laboratory, the stent graft was found totally deployed and the reported failure could not be reproduced; however new issues were identified.The tip was found invaginating; which could be a cause of the several attempts performed to deploy the stent graft.The outer sheath was found kinked in two parts and tore of in one of them.It is not known when and how the kinks and the tore off of the outer sheath occurred and they are assessed as being incidental findings.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.Regarding preparation of the device the instructions for use state 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.' 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 10f and a 0.035" guidewire.Regarding the precautions can be found that 'the safety and effectiveness of the device for use in the treatment of aneurysms and pseudoaneurysms have not been established.¿ h10: b5, d4 (expiry date: 08/2023).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.

• 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: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 12924148
• MDR Text Key: 282614846
• Report Number: 9681442-2021-00612
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00801741145339
• UDI-Public: (01)00801741145339
• 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: 01/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: FVL14040
• Device Lot Number: ANEV3743
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2022
• 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 Age: 77 YR
• Patient Sex: Male
• Patient Weight: 65 KG