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

Catalog Number FEM07100

Device Problems Material Invagination (1336); Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/17/2016

Event Type  malfunction  

Manufacturer Narrative

The device history records are being reviewed.The event is currently under investigation.

Event Description

It was reported that the endovascular stent graft should be placed in the upper arm during a fistulogram procedure.During sheathless insertion of the stent delivery system, resistance was felt and the device could not be advanced over the guide wire to the lesion site through the tracking anatomy.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.During the evaluation of the returned delivery system, the distal tip was found to be invaginated; may be as a consequence of the reported difficulties in inserting the device into the patient's body.During the performed patency test, a device compatible 0.035" guide wire could be inserted into and advanced through the delivery system without issue.Potential contributing factors to the reported event have been considered.Previous investigations of similar complaints have been reviewed.This type of event may be associated with insufficient flushing of the device.Not using an introducer sheath may be another contributing factor to the reported insertion difficulties finally resulting in the deformation of the tip.In this case, no introducer sheath was used.Rough handling of the device during unpacking or preparation also may contribute to the reported event.On the basis of the information available and the evaluation of the sample, a definite root cause for the reported event could not be determined.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." also the ifu states: "prior to loading the endovascular system over a guide wire, both ports must be flushed with sterile saline." furthermore, the ifu indicates that an introducer sheath of appropriate inner diameter is required for the procedure.Updated 'eval code & desc - conclusion' due to completion of evaluation.

Event Description

It was reported that the endovascular stent graft should be placed in the upper arm during a fistulogram procedure.During sheathless insertion of the stent delivery system, resistance was felt and the device could not be advanced over the guide wire to the lesion site through the tracking anatomy.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; wachhausstr. 6; karlsruhe 76227 ; GM 76227
• Manufacturer (Section G): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG -9681442; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• Manufacturer Contact: daniela mueller ; wachhausstr. 6; karlsruhe 76227 ; GM 76227 ; 0497219445
• MDR Report Key: 6311862
• MDR Text Key: 66826405
• Report Number: 9681442-2017-00049
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 04049519008462
• UDI-Public: (01)04049519008462(17)190513(10)ANAS1266
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 04/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/13/2019
• Device Catalogue Number: FEM07100
• Device Lot Number: ANAS1266
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/13/2016
• 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 Age: 77 YR
• Patient Weight: 101