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

Catalog Number UNKNOWN

Device Problems Fracture (1260); Kinked (1339); Occlusion Within Device (1423)

Patient Problem Thromboembolism (2654)

Event Type  Injury  

Manufacturer Narrative

No medical records or no medical images have been made available to the manufacturer.As the lot number for the device was not provided, a review of the device history records will not be performed.The device has not been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.The catalog number identified has not been cleared in the us, but is similar to the fluency plus vascular stent graft products that are cleared in the us.The 510 k number and pro code for the fluency plus vascular stent graft products are identified.Accordingly, this event has been determined to be mdr reportable.Journal article review: a patient was admitted for an enlarging popliteal artery aneurysm (paa).The paa was treated with implantation of a fluency covered stent graft.Three months after implantation, stent fractures and stent kinking were detected at the proximal and distal sites of the popliteal artery.Six months after implantation, a thromboembolism occurred in the stent graft and is attributed to the stent kinking and fractures.Balloon dilatation and thrombus aspiration was performed initially to treat the lesion however a solid thrombus still remained.The physicians then decided to implant a 10.0 x 40 mm s.M.A.R.T self-expandable nitinol stent to cover the fracture and kinking and reinforce it from the inside.No vascular event occurred during 4.5 years of follow-up after reintervention.The state of the patient is unknown.Nishi m, zen k, yamaguchi s, asada s, kambayashi d (2015).Popliteal artery aneurysm treated with implantation of a covered stent graft (fluency) reinforced with a nitinol stent (s.M.A.R.T.), 31, 316-320.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 in an article in the japanese association of cardiovascular intervention and therapeutics titled 'popliteal artery aneurysm treated with implantation of a covered stent graft (fluency) reinforced with a nitinol stent (s.M.A.R.T.)', a covered stent graft was implanted in a patient to treat a popliteal artery aneurysm.Stent fractures and stent kinking were detected 3 months after implantation at the proximal and distal sites of the popliteal arteries and then a thromboembolism was found in the stent graft 6 months after implantation.Balloon dilatation and thrombus aspiration was used to treat the lesion however a thrombus still remained.A self-expandable nitinol stent was then implanted in the proximal part of the stent to cover the fracture and kinking and reinforce it from the inside.Patency of the popliteal artery remained after 4.5 years of follow-up.Current patency of the popliteal artery is unknown.

Manufacturer Narrative

Manufacturing review: the lot number was not reported so that manufacturing records could not be reviewed.It was therefore not known whether a potential manufacturing related issue may have caused the alleged failure.Investigation summary: based on the images provided it could be confirmed that the stent graft was occluded 6m after placement; however a relation to the device could not be confirmed.A kink of the stent graft or a strut fracture could not be confirmed, but the stent was following the curved vessel geometry and a minor dent may have been present on the inner radius of the stent graft in that curve caused by radius adapting stent material; a deficiency of the placed stent graft could not be identified.As a result of the investigation performed the complaint is inconclusive.Potential factors which may have caused or contributed to the reported issue have been considered.A definite root cause for the reported event could not be determined.The reported application represents an off label use of the device.Labeling review: in reviewing the applicable ifu for this product the potential risk was found addressed as the ifu states: 'the fluency plus biliary stent graft is indicated for use in the treatment of biliary strictures resulting from malignant neoplasms', and 'the safety and effectiveness of this device for use in the vascular system have not been established.' the ifu further states: 'in order to ensure adequate wall apposition, slight oversizing with reference to the non-stenotic proximal and distal healthy duct diameter is recommended.' stent graft fracture is mentioned as a potential adverse event.Journal article review: a patient was admitted for an enlarging popliteal artery aneurysm (paa).The paa was treated with implantation of a fluency covered stent graft.3 months after implantation, stent fractures and stent kinking were detected at the proximal and distal sites of the popliteal artery.6 months after implantation, a thromboembolism occurred in the stent graft and is attributed to the stent kinking and fractures.Balloon dilatation and thrombus aspiration was performed initially to treat the lesion however a solid thrombus still remained.The physicians then decided to implant a 10.0 x 40 mm s.M.A.R.T self-expandable nitinol stent to cover the fracture and kinking and reinforce it from the inside.No vascular event occurred during 4.5 years of follow-up after reintervention.The state of the patient is unknown.Nishi m, zen k, yamaguchi s, asada s, kambayashi d (2015).Popliteal artery aneurysm treated with implantation of a covered stent graft (fluency) reinforced with a nitinol stent (s.M.A.R.T.), 31, 316-320.(b)(4).

Event Description

It was reported in an article in the (b)(4) association of cardiovascular intervention and therapeutics titled 'popliteal artery aneurysm treated with implantation of a covered stent graft (fluency) reinforced with a nitinol stent (s.M.A.R.T.)', a covered stent graft was implanted in a patient to treat a popliteal artery aneurysm.Stent fractures and stent kinking were detected 3 months after implantation at the proximal and distal sites of the popliteal arteries and then a thromboembolism was found in the stent graft 6 months after implantation.Balloon dilatation and thrombus aspiration was used to treat the lesion however a thrombus still remained.A self-expandable nitinol stent was then implanted in the proximal part of the stent to cover the fracture and kinking and reinforce it from the inside.Patency of the popliteal artery remained after 4.5 years of follow-up.Current patency of the popliteal artery is unknown.

• Brand Name: FLUENCY PLUS BILIARY STENT GRAFT
• Type of Device: BILIARY STENT GRAFT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• Manufacturer (Section G): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• Manufacturer Contact: judith ludwig ; 1625 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 6726345
• MDR Text Key: 80495094
• Report Number: 9681442-2017-00223
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P130029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/19/2017
• 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
• Patient Age: 60 YR