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

Catalog Number FVL07120

Device Problems Break (1069); Difficult to Remove (1528); Activation Failure (3270)

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

Event Date 10/19/2022

Event Type  malfunction  

Event Description

It was reported that during a stent graft placement procedure via iliac, the stent was allegedly not fully expanded.It was further reported that the guidewire was allegedly stuck to delivery system and did not come off.There was no reported patient injury.

Manufacturer Narrative

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.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 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: 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 sample was returned for evaluation.In the returned sample, the stent graft had been deployed already.The inner catheter was missing in the sample, however a segment of the inner catheter was found stuck to the guidewire that was returned along with the sample confirming difficult removal over the wire.Provided images demonstrate the placed stent grafts in the bilateral iliac arteries with ends of the stent grafts being placed in the aorta; the diameter of the stent grafts is slightly increased after post pta, and evenly expanded; expansion failure cannot be confirmed.A stuck inner catheter is not visible on the images.The device was reportedly flushed and a system compatible guidewire was used.The target vessel in this case was reportedly calcified.The images could not provide a clear picture of the oversizing.Additionally the system should be straightened prior to deployment and the proximal end of the stent graft should be placed in a straight section of the lumen prior to deployment.In this case these steps were reportedly followed.Based on the provided information the investigation is closed with a confirmation for the failure code 'difficult to remove' and break.The placement of a portion of the stent graft in the aorta is an off-label use.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 post dilation it says: 'careful post dilatation of the implanted stent graft is required with a balloon equal in diameter to the diameter of the stent graft.' 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 9f and a 0.035" guidewire.The instructions for use includes a covered stent diameter selection table describing the recommended oversizing.Regarding indications for use it states: 'for use in the iliac and femoral arteries¿.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 graft placement procedure via iliac, the stent was allegedly not fully expanded.It was further reported that the guidewire was allegedly stuck to delivery system and did not come off.There was no reported patient injury.

• 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: 15832871
• MDR Text Key: 305597146
• Report Number: 9681442-2022-00334
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00801741145063
• UDI-Public: (01)00801741145063
• Combination Product (y/n): N
• Reporter Country Code: TU
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: FVL07120
• Device Lot Number: ANFR0832
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2023
• 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 Age: 63 YR
• Patient Sex: Male