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

Catalog Number	FEM08100
Medical Device Problem Codes	Material Invagination (1336); Failure to Advance (2524); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/08/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history records are being reviewed.The event is currently under investigation.
Event or Problem Description
It was reported that during the attempt to load the stent delivery system onto a 0.035" guide wire prior to the procedure, the outer tip of the delivery system became detached.Reportedly, the blue portion of the catheter was noticeable.Another stent graft was used with the same guide wire to perform the procedure.There was no patient involvement.
Additional 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.The evaluation of the returned device revealed that the deployment mechanism had not been used and that both the inner and outer catheter tip were invaginated in the tip section.The reported detachment could not be confirmed.Potential factors that may have caused or contributed to the reported event have been evaluated.As the reported event was found to be an isolated incident, no investigations of similar complaints could have been reviewed.During the evaluation, the tip section of the delivery system was found to be invaginated.This type of event may be associated with the use of an inappropriate guide wire or insufficient flushing of the device.Rough handling of the device during unpacking or preparation also may contribute to this type of event.On the basis of the information available and the evaluation of the returned device, a definite root cause for the reported event could not be determined.The ifu states that the device must be flushed with sterile saline.Furthermore, the ifu states: "if unusual resistance or high deployment force is encountered during stent graft deployment, abort the procedure, remove the delivery system and use an alternative device." also the ifu indicates that a 0.035" guide wire is required for the procedure.
Event or Problem Description
It was reported that during the attempt to load the stent delivery system onto a 0.035" guide wire prior to the procedure, the outer tip of the delivery system became detached.Reportedly, the blue portion of the catheter was noticeable.Another stent graft was used with the same guide wire to perform the procedure.There was no patient involvement.

• Brand Name: FLUENCY PLUS ENDOVASCULAR STENT GRAFT
• Common Device Name: ENDOVASCULAR STENT GRAFT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 5980142
• Report Number: 9681442-2016-00250
• Device Sequence Number: 11163529
• Product Code: PFV
• UDI-Device Identifier: 04049519008516
• UDI-Public: (01)04049519008516(17)181221(10)ANZL2079
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P130029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2016

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/21/2018
• Device Catalogue Number: FEM08100
• Device Lot Number: ANZL2079
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/08/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/27/2016
• Supplement Report FDA Received Date: 11/07/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 73