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

Catalog Number UNK FLUENCYPLUS ENDO STNT GRFT

Device Problems Material Erosion (1214); Fracture (1260); Migration or Expulsion of Device (1395)

Patient Problems No Known Impact Or Consequence To Patient (2692); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/09/2012

Event Type  Injury  

Manufacturer Narrative

As no lot number was provided, a device history record review could not be performed.The information provided by bard 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 bard.

Event Description

It was reported through an article in the journal of vascular surgery titled "complications of endovascular grafts in the treatment of pseudoaneurysms and stenoses in arteriovenous access", that an unknown number of stent grafts was used and that during a 44 month period, several patients presented with complications which included migration, fracture and erosion.The number of devices that were involved is unknown and the deficiencies were not linked to a specific device; therefore, one complaint was conservatively opened to capture the events.Detailed patient outcomes have not been reported.

Manufacturer Narrative

As no specific lot number was provided, a device history record review could not be performed.As no sample was returned and the images that were part of the journal article could not clarify the relationship between a specific product and failure mode, the reported event could not be reproduced.As per the information provided in the article, no specific failure mode related to a specific product was reported.The use of an endovascular stent graft for treatment of an aneurysm is considered an off-label use as the device is indicated for the treatment of stenosis at the venous anastomosis of eptfe or other synthetic arteriovenous (av) access grafts, not for use in the treatment of pseudoaneurysms.It is unknown whether the relevant products were used for pseudoaneurysm treatment.On the basis of the limited information available, no further investigation could be performed and no root cause could be determined.The ifu supplied with this device states that complications and adverse events associated with use of the fluency plus endovascular stent graft may include the usual complications associated with endovascular stent and stent graft placement and dialysis shunt revisions.The ifu also states that the safety and effectiveness of the device when placed across an aneurysm or a pseudoaneurysm has not been evaluated.

Event Description

It was reported through an article in the journal of vascular surgery titled "complications of endovascular grafts in the treatment of pseudoaneurysms and stenoses in arteriovenous access" that an unknown number of stent grafts was used and that during a 44 month period, several patients presented with complications which included migration, fracture and erosion.The number of devices that were involved is unknown and the deficiencies were not linked to a specific device; therefore, one complaint was conservatively opened to capture the events.Detailed patient outcomes were not reported.

Manufacturer Narrative

H10: manufacturing review: a lot history review, a device history record review and complete manufacturing review could not be conducted for the investigation as the lot number is unknown.Investigation summary: the sample wad not returned for evaluation.Three images that were part of the journal article could not clarify the relationship between a specific product and failure mode.Therefore, the investigation is inconclusive for reported issues.A definite root cause for the reported event could not be determined.Labeling review: in reviewing current instructions for use it was found that the instructions for use sufficiently addressed the potential risk.The instructions for use states: 'complications and adverse events associated with use of the fluency plus endovascular stent graft may include the usual complications associated with endovascular stent and stent graft placement and dialysis shunt revisions.These may include the following: allergic reaction, aneurysm, arm or hand edema, bleeding at access site, blood leakage from delivery system (hemostasis), bond joint failures, cellulitis, cerebrovascular accident, congestive heart failure, death, delivery system kinking, detachment of part, face or neck edema, failure to deploy, fever, hematoma, hemoptysis, hemorrhage, high deployment forces, inability to track to target location, inaccurate deployment, incompatibility with accessory devices, infection, insufficient stent graft expansion, no visibility under fluoroscopy, pain, perforation, premature deployment, prolonged bleeding, pseudoaneurysm, rash, reaction to contrast, restenosis requiring reintervention, sepsis, steal syndrome, stent graft embolism, stent graft fracture, stent graft kinking, stent graft migration, stent graft misplacement, thrombotic occlusion, ventricular fibrillation, or vessel rupture.' the instructions for use further states that the safety and effectiveness of the device when placed across an aneurysm or a pseudoaneurysm has not been evaluated.Jill nicole zink, robert netzley, victor erzurum and dennis wright (2012).Complications of endovascular grafts in the treatment of pseudoaneurysms and stenoses in arteriovenous access.Journal of vascular surgery, 57(1):144-8.Doi: 10.1016/j.Jvs.2012.06.087.H11: g1, h6 (patient, method, conclusion).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 through an article in the journal of vascular surgery titled "complications of endovascular grafts in the treatment of pseudoaneurysms and stenoses in arteriovenous access", during a 44 month period, eleven patients presented with complications which included migration, fracture and erosion.

• Brand Name: FLUENCY PLUS ENDOVASCULAR STENT GRAFT
• Type of Device: ENDOVASCULAR STENT GRAFT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• Manufacturer (Section G): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG -9681442; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• Manufacturer Contact: brett curtice ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032772
• MDR Report Key: 6526122
• MDR Text Key: 73871488
• Report Number: 9681442-2017-00158
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK FLUENCYPLUS ENDO STNT GRFT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/30/2017
• Initial Date FDA Received: 04/27/2017
• Supplement Dates Manufacturer Received: Not provided; 06/08/2022
• Supplement Dates FDA Received: 05/31/2017; 07/05/2022
• 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
• Patient Outcome(s): Required Intervention