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

Catalog Number FVL10040

Device Problems Break (1069); Material Perforation (2205); Misfire (2532); Contamination /Decontamination Problem (2895)

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

Event Date 01/04/2023

Event Type  malfunction  

Event Description

It was reported that during a stent placement procedure in portal vein, the stent allegedly had partial deployment.It was further reported that the stent was allegedly broken and was removed as a whole.The procedure was completed by using another device.There was no reported patient injury.

Manufacturer Narrative

The catalog number identified 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 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.Expiry date: 03/2023.

Event Description

It was reported that during a stent placement procedure in portal vein, the stent allegedly had partial deployment.It was further reported that the stent was allegedly broken and was removed as a whole.The 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 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 for evaluation.The investigation of the reported event is currently underway.H10: d4 (expiry date: 03/2023), g3, h6 (device) h11: d4 (medical device lot number), h6 (method) 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: 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 delivery system was returned for evaluation and the stent graft was found partially deployed.There is foreign material woven around the stent graft, but the origin of this material is unknown, no similar material is used during the manufacturing process.It was reported that the delivery system was flushed, device compatible guidewire was used, the lesion was not tortuous, and it was pre-dilated.During evaluation, a foreign material was found woven around the stent graft, but the origin of this material is unknown, and it was confirmed that no similar material is used during the manufacturing process.Based on returned sample analysis, the investigation of the reported partial deployment is confirmed.A foreign material was found attached to the stent graft.A definite root cause for the reported event as well as for the foreign material could not be determined.The stent graft was intended to be placed in the portal vein, which represents an off-label use.Labeling review: in reviewing the relevant labeling, it was found that the instructions for use sufficiently address the potential risks.Regarding stent deployment, the instructions for use states "if resistance is encountered removing the delivery system, it is recommended to remove the delivery system, introducer and guidewire as a single unit".Regarding preparation of the device the instructions for use states that "prior to loading the endovascular 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".With regards to directions for use, the instructions for use states "prepare a stiff 0.035" guidewire per its instructions for use and advance the guidewire under fluoroscopy to the target location".Regarding the placement site, instructions for use states: "vascular stent graft.For use in the iliac and femoral arteries".Based on reported information, the intended placement site for this stent was the venous system which represents off-label use.H10: d4 (expiry date: 03/2023), g3, h2 h11: b5, h6 (device, result, conclusion), g1 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 : see h10.

Event Description

It was reported that the stent could not deployed completely during a stent placement procedure in the portal vein.It was further reported the delivery system was alleged to be broken due to repeated withdrawal and removal.The device was removed and another device was used to complete the procedure.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: 16270581
• MDR Text Key: 308473439
• Report Number: 9681442-2023-00012
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00801741145216
• UDI-Public: (01)00801741145216
• 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: 05/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: FVL10040
• Device Lot Number: ANEQ2295
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/04/2023
• Initial Date FDA Received: 01/31/2023
• Supplement Dates Manufacturer Received: 03/24/2023; 05/19/2023
• Supplement Dates FDA Received: 04/21/2023; 05/25/2023
• 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