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

Catalog Number UNK FLUENCYPLUS VASC STNT GRFT

Device Problems Fracture (1260); Migration or Expulsion of Device (1395); Off-Label Use (1494)

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

Event Date 11/02/2022

Event Type  malfunction  

Event Description

It was reported in an article in the journal of ¿vascular surgery¿ titled ¿analysis of predisposing factors for type iii endoleak from directional branches after branched endovascular repair for thoracoabdominal aortic aneurysms", one out of one hundred and thirty-eight stents fractured, and one out of one hundred and thirty-eight stents disconnected from the aortic cuff.There was no reported patient injury.

Manufacturer Narrative

H10: as this malfunction is considered one event identified by the dealer; only one mdr report will be submitted for the reported quantity affected of two for this event.H10: as the lot number for the device was not provided, a review of the device history records could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.H10: (b)(6) et.Al., (2022).Analysis of predisposing factors for type iii endoleaks from directional branches after branched endovascular repair for thoracoabdominal aortic aneurysms.Journal of vascular surgery, (b)(6).Doi: 10.1016/j.Jvs.2022.10.041.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 : device not returned.

Event Description

It was reported in an article in the journal of ¿vascular surgery¿ titled ¿analysis of predisposing factors for type iii endoleak from directional branches after branched endovascular repair for thoracoabdominal aortic aneurysms", one out of one hundred and thirty-eight stents fractured, and one out of one hundred and thirty-eight stents disconnected from the aortic cuff.There was no reported patient injury.

Manufacturer Narrative

The fda rn number for the initial mdr was inadvertently submitted as 2020394.The correct fda rn number was 9681442.As this malfunction is considered one event identified by the dealer; only one mdr report will be submitted for the reported quantity affected of two for this event.Manufacturing review: as the lot number for the device was not provided, a review of the device history records could not be performed.Investigation summary: the physical device was not returned for evaluation.No images were provided for review.Based on the information available, it was reasonably suggested that the off-label use has contributed significantly to these events, respectively that the off-label created the potential for its occurrence.Furthermore, it can be reasonably suggested that the users in these cases were aware of the off-label use of the products.Labeling review: current version of relevant labeling applicable for this product was reviewed.Based on the instructions for use the fluency¿ plus vascular stent graft is indicated for the treatment of atherosclerotic lesions in the iliac arteries.Therefore, the use of the device as a bridging stent during branched endovascular repair for thoracoabdominal aortic aneurysm represents an off label use.Precautions were found included in the instructions for use; e.G., "the safety and effectiveness of the device for use in the treatment of aneurysms and pseudoaneurysms have not been established." stefano gennai, gioele simonte, migliari mattia, nicola leone, giacomo isernia, gianluigi fino, et.Al., (2022).Analysis of predisposing factors for type iii endoleaks from directional branches after branched endovascular repair for thoracoabdominal aortic aneurysms.Journal of vascular surgery, 77(3):677-684.Doi: 10.1016/j.Jvs.2022.10.041.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.

• Brand Name: FLUENCY PLUS VASCULAR STENT GRAFT
• Type of Device: VASCULAR STENT GRAFT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstr. 6; karlsruhe AZ 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: 17585563
• MDR Text Key: 322366004
• Report Number: 2020394-2023-00588
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P130029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/10/2023

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: UNK FLUENCYPLUS VASC STNT GRFT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/25/2023
• Initial Date FDA Received: 08/21/2023
• Supplement Dates Manufacturer Received: 09/05/2023
• Supplement Dates FDA Received: 09/13/2023
• 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