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

Catalog Number UNK FLUENCY

Device Problem Obstruction of Flow (2423)

Patient Problem Stenosis (2263)

Event Date 01/31/2018

Event Type  Injury  

Manufacturer Narrative

The product identified for this event has not been cleared in the us, but is similar to the fluency plus endovascular stent graft products that are cleared in the u.S.Accordingly, this event has been determined to be mdr reportable.Manufacturing review: as the lot number for the device was not provided, a manufacturing review could not be performed.Journal article citation: wen, d., wang, z., yu, j., zhang, w., yang, x., he, h.,.Xu, j.(2018).Endovascular stent-graft repair of spontaneous isolated dissection of the superior mesenteric artery.Cardiovascular and interventional radiology, 41 (5), 692-698.Http:// doi.Org/10.1007/s00270-018-1889-0.Investigation summary: based on the investigation of the journal article and the attached images a stenosis could not be confirmed.The images attached to the article were found with poor resolution and did not document a device deficiency.An indication for a device relation of the vessel occlusion could not be determined.Therefore, the results of the investigation are inconclusive.Potential factors which may have caused or contributed to the reported issue have been considered.In this case, poor information was provided in regards to patient/vasuar condition, but the stent graft was successfully placed with normal blood flow.Based on the information available, a definite root cause for the reported failure could not be determined.Labeling review: in reviewing the relevant ifu for the endovascular product the potential risk was found addressed as the ifu 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: (.) restenosis requiring reintervention (.) thrombotic occlusion'.The fluency plus endovascular stent graft is indicated for use in the treatment of in-stent restenosis in the venous outflow of hemodialysis patients dialyzing by either an arteriovenous (av) fistula or av graft and for the treatment of stenosis in the venous outflow of hemodialysis patients dialyzing by an av graft.Note, the fluency vascular stent graft is intended for use in the iliac and femoral arteries.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 cardiovascular and interventional radiology, in an article titled, ¿endovascular stent-graft repair of spontaneous isolated dissection of the superior mesenteric artery', that stent stenosis was identified in one patient after 22 months.No reported intervention was performed.Patient status is unknown.

• Brand Name: FLUENCY 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; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• Manufacturer Contact: judith ludwig ; 1625 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 7741451
• MDR Text Key: 115765560
• Report Number: 9681442-2018-00121
• Device Sequence Number: 1
• Product Code: PFV
• 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: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK FLUENCY
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/05/2018
• 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): Other
• Patient Age: 57 YR