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

Model Number FEM12060

Device Problems Break (1069); Detachment of Device or Device Component (2907); Activation Failure (3270)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/21/2018

Event Type  malfunction  

Manufacturer Narrative

No medical records were provided to the manufacturer, however, an x-ray image was provided and is pending review.The lot number for the device was provided.The device history records are currently under review.The delivery system has been returned for evaluation.The investigation is currently underway.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 that post balloon dilatation of the distal end of an existing stent, this stent graft was successfully deployed over lapping the existing stent via the brachial access to further treat a moderate tortuous vessel.However, the distal end of the stent graft allegedly failed to fully expand.Therefore, several pta balloons were reportedly used in order to fully expand the stent graft and complete the procedure.There was no reported difficulty in retracting the delivery system from the patient.There was no reported patient injury.

Event Description

It was reported that post balloon dilatation of the distal end of an existing stent, this stent graft was successfully deployed over lapping the existing stent via the brachial access to further treat a moderate tortuous vessel.However, the distal end of the stent graft allegedly failed to fully expand.Therefore, several pta balloons were reportedly used in order to fully expand the stent graft and complete the procedure.There was no reported difficulty in retracting the delivery system from the patient.There was no reported patient injury.

Manufacturer Narrative

Manufacturing review: based on the information available and the investigation performed, there is no indication that the product failed to meet its specification prior to shipment.The lot records have been reviewed with special attention to the manufacturing and inspection of this product and the product was found to have met the specification prior to shipment.The review shows that no remarkable incidents occurred during the manufacturing process.No relevant manufacturing process changes were implemented, that could have led to the event reported.Based on the evaluation of the provided x-ray image and the returned sample the reported issue could be confirmed as one end of the stent was found to be not expanded.Based on the evaluation of the delivery system the catheter tip incl.Marker band was found broken off which could caused the reported failure to expand.However, as reported by the hospital staff (x-ray technician) the distal tip and marker are not believed to be in the patient.Based on sample evaluation no indication was found that a manufacturing related issue may have caused the breakage respectively the reported failure to expand.Based on the information available a definite root cause for the reported event could not be determined.In reviewing the labeling supplied with this product it was found that the instructions for use (ifu) sufficiently address the potential risks.Regarding preparation of the treatment site the ifu states: "pre-dilate the lesion and confirm that the stenosed lumen can be dilated to the desired diameter." furthermore, the ifu states "post dilate the stent graft with an angioplasty balloon sized appropriately as to ensure complete wall apposition to the reference vessel.".

• 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
• MDR Report Key: 7881901
• MDR Text Key: 120521610
• Report Number: 2020394-2018-01719
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 04049519008646
• UDI-Public: (01)04049519008646
• Combination Product (y/n): N
• PMA/PMN Number: P130029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FEM12060
• Device Catalogue Number: FEM12060
• Device Lot Number: ANCS2367
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2018
• Initial Date Manufacturer Received: 08/21/2018
• Initial Date FDA Received: 09/17/2018
• Supplement Dates Manufacturer Received: 10/18/2018
• Supplement Dates FDA Received: 10/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 68