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

Catalog Number FVL12040

Device Problem Material Deformation (2976)

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

Event Date 11/07/2023

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 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 return of the sample is pending.The investigation of the reported event is currently underway.H10: d4 (expiry date: 04/2025).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 pending return.

Event Description

It was reported that during a stent graft placement procedure in the left subclavian artery, the head end of the stent was allegedly found to be damaged and could not be used continuously.The procedure was completed by using another device.There was no reported patient injury.

Event Description

It was reported that during a stent graft placement procedure in the left subclavian artery, the head end of the stent was allegedly found to be damaged and could not be used continuously.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: 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 and the stent graft was completely deployed and returned as part of sample; the inner catheter was protruding the tip.The outer sheath was found elongated, indication increased forces during deployment.However, no damage was of the distal end of the catheter nor the deployed stent graft was found.Based on provided information and the evaluation of the returned sample, the investigation is closed with inconclusive results for device damage.A definite root cause for the reported event could not be determined.The intended placement of the device for stenting in the left subclavian artery 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.The instructions for use state: "visually inspect the fluency plus vascular stent graft to verify that the device has not been damaged due to shipping or improper storage.Do not use a damaged device".The fluency plus vascular stent graft is indicated for the treatment of atherosclerotic lesions in the iliac arteries.The intended placement of the device for stenting in the left subclavian artery represents an off-label use.H10: d4 (expiration date: 04/2025), g3 h11: h6 (method, result, conclusion) 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 : see h10.

• 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: 18225841
• MDR Text Key: 329199545
• Report Number: 9681442-2023-00383
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00801741145278
• UDI-Public: (01)00801741145278
• 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: 12/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: FVL12040
• Device Lot Number: ANGR2302
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2023
• 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