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

Catalog Number FEM07120

Device Problems Fracture (1260); Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/13/2016

Event Type  Injury  

Manufacturer Narrative

The event is currently under investigation.The correct lot number of the subject device is unknown to date.Reportedly, it is either anaq3395 or anaq0733.Therefore, the lot history records of both lot numbers are being reviewed.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant was unable to provide any further product details to date.

Event Description

It was reported that upon inflation of a pta balloon post stent graft placement in a pre-dilated lesion of the cepaphalic vein, extravasations were noticed and the stent graft allegedly ruptured.Due to the rupture, another stent graft of the same brand was used to complete the procedure successfully.There was no reported patient injury.

Manufacturer Narrative

The lot history records have been reviewed with special attention to the manufacturing and inspection of this product and the product was found to have met all specifications prior to shipment.There is no indication for a manufacturing-related failure.On the basis of the four returned delivery systems, the reported event could not be reproduced.The stent grafts of the four delivery systems were found to be released upon sample receipt but not returned.None of the returned devices showed any device deficiency.Also during the evaluation of the returned balloon catheter no defect or deficiency was identified.As no image showing the deployed stent graft was provided, the reported event of a stent graft rupture could not be verified.Potential contributing factors to the reported event have been considered.As the reported event was determined to be an isolated incident, no previous investigations of similar complaint could have been reviewed.The reported event may be related to a difficult vessel anatomy or improper balloon dilation.In this case, pre and post dilation of the lesion was being performed by using an appropriately sized balloon catheter.Reportedly, the anatomy of the tracking vessel was neither tortuous nor calcified.On the basis of the information available, the evaluation of the returned devices and as no images were provided, a definite root cause for the reported event could not be determined.The ifu states: "post-dilation of the stent graft must be performed with a pta balloon catheter no larger than the previously placed bare metal stent." and "the stent graft implant cannot be expanded with an angioplasty balloon beyond its stated diameter." furthermore, the ifu states: "examine the packaging and endovascular system to determine if there is any damage, defects or if the sterile barrier is compromised.Do not use the device if any of these conditions are observed.".

Event Description

It was reported that upon inflation of a pta balloon post stent graft placement in a pre-dilated lesion of the cephalic vein, extravasations were noticed and the stent graft allegedly ruptured.Due to the rupture, another stent graft of the same brand was used to complete the procedure successfully.There was no reported patient injury.

• 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: daniela mueller ; wachhausstrasse 6; karlsruhe 76227 ; GM 76227 ; 0497219445
• MDR Report Key: 5864625
• MDR Text Key: 51731368
• Report Number: 9681442-2016-00219
• 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: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/13/2016

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: FEM07120
• Device Lot Number: ANAQ3395 OR ANAQ0733
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/13/2016
• Initial Date FDA Received: 08/10/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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: 87 YR
• Patient Weight: 44