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

Catalog Number FVL08080

Device Problem Misfire (2532)

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

Event Date 04/09/2023

Event Type  malfunction  

Manufacturer Narrative

H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the fluency plus vascular stent graft that are cleared in the us.The pro code and 510 k number for the fluency plus vascular 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, a video was provided for review.The investigation of the reported event is currently underway.H10: d4 (expiry date: 03/2025).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 not returned.

Event Description

It was reported that during a stent graft placement procedure via the right femoral artery and the right internal jugular vein, the guide wire was inserted in the internal vein and the radiographic catheter was introduced for radiography.The stent was delivered to the designated site for release, the stent was allegedly partially deployed.The stent was removed and procedure was completed by 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 vascular stent graft that are cleared in the us.The pro code and 510 k number for the fluency plus vascular 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 delivery system was not returned for evaluation.A short video clip was provided showing the stent covered partially released from the sheath.It is not known at which point of the procedure this video was taken and what happened during the remaining procedural time, which leads to inconclusive results for partial deployment.It was reported that the device was flushed, a 0.035" hydrophilic guidewire/9f introducer were used, there was no serious calcification and the device was held in the straight section of the vessel prior to deployment attempts.Based on the provided information and the evaluation of the provided video, the investigation is closed with inconclusive results for partial deployment.A definite root cause could not be determined based upon the available information.The intended use of the device in the tips procedure represents an off-label use.Labeling/packaging 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 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 9f and a 0.035" guidewire.The fluency vascular stent graft is indicated for use in the iliac and femoral arteries.The use of this device in the tips procedure represents an off-label use.H10: (expiration date: 03/2025).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 via the right femoral artery and the right internal jugular vein, the guide wire was inserted in the internal vein and the radiographic catheter was introduced for radiography.It was further reported that the stent was delivered to the designated site for release and during the release, the stent tip was deployed but allegedly got stuck, making continuous release impossible.Reportedly, the stent was removed and procedure was completed by using another device.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: 16884456
• MDR Text Key: 314709100
• Report Number: 9681442-2023-00173
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00801741145117
• UDI-Public: (01)00801741145117
• 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
• Report Date: 05/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: FVL08080
• Device Lot Number: ANGQ1672
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/26/2023
• 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