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

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Embolism (1829)

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 balloon 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: the patient was implanted with a fluency plus vascular stent graft in the left common external iliac artery for a pseudoaneurysm.A left leg embolus was noted following the procedure.The embolus was treated by fogarty embolectomy.Six months after implantation of the stent, the left leg was amputated.The state of the patient is unknown.Maria ierardi a, kehagias e, piffaretti g, piacentino f, de marchi g, matteo t, ioannou c, tonolini m, magenta biasina a, carrafiello g, tsetis d (2015).Eptfe stent graft in non-steno-occlusive arterial disease: 2 centers retrospective study.Italian society of medical radiology, 121, 482-493.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 italian society of medical radiology titled "eptfe stent graft in non-steno-occlusive arterial disease: 2 centers retrospective study," after implantation of an endovascular stent at the left common external iliac artery, a distal thrombus embolism was found.The embolus was treated by fogarty embolectomy.Six months after stent implantation, the patient's left leg was amputated.The state of the patient is unknown.

Manufacturer Narrative

Manufacturing review: the lot number was not reported; therefore, manufacturing records could not be reviewed.Visual/microscopic inspection: a visual/microscopic inspection could not be performed as the device was not available.Functional/performance evaluation: a functional/performance evaluation could not be performed as the device was not available medical records review_: medical records were not provided.Image/photo review: 12 images were part of the journal article.The images demonstrated different topics of stent graft placement.However, the author did not identify the products that were demonstrated on the images.In addition a specific failure could not be identified on the images.The author described that the product was used for pseudoaneurysm treatment.Conclusion: as a result of the investigation performed the complaint is inconclusive.A definite root cause for the reported event could not be determined.The reported application represents an off label used of the device.Based on the information available a definite root cause for the reported failure could not be determined.Labeling review: the current ifu (instructions for use) states: in reviewing the current ifu for the vascular product the potential risk was found addressed as the ifu states: 'all complications that have been reported in association with conventional vascular stents and stent grafts may also occur during or after insertion of a fluency plus vascular stent graft.These include (.) thrombosis (.) early stent graft occlusion and restenosis'.The ifu further states: 'the safety and effectiveness of the device for use in the treatment of aneurysms and pseudoaneurysms have not been established.' journal article review: the patient was implanted with a fleuncy plus vascular stent graft in the left common external iliac artery for a pseudoaneurysm.A left leg embolus was noted following the procedure.The embolus was treated by fogarty embolectomy.Six months after implantation of the stent, the left leg was amputated.The state of the patient is unknown.Maria ierardi a, kehagias e, piffaretti g, piacentino f, de marchi g, matteo t, ioannou c, tonolini m, magenta biasina a, carrafiello g, tsetis d (2015).Eptfe stent graft in non-steno-occlusive arterial disease: 2 centers retrospective study.Italian society of medical radiology, 121, 482-493.

Event Description

It was reported in an article in the italian society of medical radiology titled "eptfe stent graft in non-steno-occlusive arterial disease: 2 centers retrospective study," after implantation of an endovascular stent at the left common external iliac artery, a distal thrombus embolism was found.The embolus was treated by fogarty embolectomy.Six months after stent implantation, the patient's left leg was amputated.The state of the patient is unknown.

• Brand Name: FLUENCY PLUS VASCULAR STENT GRAFT
• Type of Device: VASCULAR 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: 6720301
• MDR Text Key: 80247946
• Report Number: 9681442-2017-00222
• 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: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 08/18/2017
• 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: 45 YR