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

Catalog Number UNKNOWN

Device Problems Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abscess (1690); Hemorrhage/Bleeding (1888)

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.Journal article review: the patient was implanted with a fluency plus vascular stent graft in the right external iliac artery for a pseudoaneurysm.During follow-up, an abscess with retroperitoneal hemorrhage was discovered that required the removal of the stent graft 1 month after implantation.Beyond the removal of the stent graft, 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 the article "eptfe stent graft in non-steno-occlusive arterial disease: 2 centers retrospective study", in the italian society of medical radiology, the vascular stent graft was removed from the right external iliac artery approximately one months post implant for abscess with retroperitoneal hemorrhage.The patient status is unknown.

Manufacturer Narrative

The catalog number identified has not been cleared in the us, but is similar to the fluency plus vascular stent products that are cleared in the us.The 510 k number and pro code for the fluency plus vascular stent products are identified.Accordingly, this event has been determined to be mdr reportable.Manufacturing review: a manufacturing review was not conducted as there was no lot number provided.Medical records review: medical recorded were not provided; therefore, a review could not be performed.Image/photo review: images/photos were not provided; therefore, a review could not be performed.Sample evaluation: the product sample was not available.Images have not been provided.Therefore, the alleged failure could not be re produced and the investigation will be closed with inconclusive result.Conclusion summary: 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 use of the device; the off label use of the device was found discussed in the report.Labeling review: in reviewing the current ifu 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 bleeding at the site of catheter placement, abscess.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 fluency plus vascular stent graft in the right external iliac artery for a pseudoaneurysm.During follow-up, an abscess with retroperitoneal hemorrhage was discovered that required the removal of the stent graft 1 month after implantation.Beyond the removal of the stent graft, 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 the article "eptfe stent graft in non-steno-occlusive arterial disease: 2 centers retrospective study", in the italian society of medical radiology, a vascular stent graft that was implanted for a pseudoaneurysm was removed from the right external iliac artery approximately one month post implant due to an abscess with retroperitoneal hemorrhage.The patient status 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: 6692005
• MDR Text Key: 79231465
• Report Number: 9681442-2017-00212
• 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: 08/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2017
• 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: 07/24/2017
• 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: 77 YR