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

Catalog Number FEM07060

Device Problems Break (1069); Difficult to Insert (1316); Device Damaged Prior to Use (2284); Split (2537)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 09/10/2015

Event Type  malfunction  

Manufacturer Narrative

The device history records are being reviewed.The event is currently under investigation.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 further patient details.The device was not used in the patient.

Event Description

It was reported that while performing a sheathless stent graft placement in the left axillary vein at a venous anastamosis with access through the left arm, the delivery system could not be inserted into the patient at the access site since the tip felt soft and even split a little.The device was not used and the procedure was completed successfully by using another stent graft.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 device, a tip damage could not be identified and the stent graft could be successfully released without difficulty.Therefore, the reported event of a soft tip including a split could not be re-produced.Potential factors that could have led or contributed to the reported event have been considered.Other investigations of similar complaints have been reviewed.The reported event may be related to rough handling of the device as this may lead to deformation and subsequent insertion difficulties.Reportedly, no introducer sheath was used during the procedure which may be another contributing factor to the reported insertion difficulties.On the basis of the information available, a definite root cause for the reported event could not be determined.The ifu recommends the use of an appropriate sized introducer sheath.Furthermore, the ifu states: "examine the packaging and endovascular system to determine if there is any damage, defect or if the sterile barrier is compromised.Do not use the device if any of these conditions are observed.".

• 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: 5136586
• MDR Text Key: 28106659
• Report Number: 9681442-2015-00180
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 04049519008448
• UDI-Public: (01)04049519008448(17)180319(10)ANZC2205
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130029/S003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 09/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/19/2018
• Device Catalogue Number: FEM07060
• Device Lot Number: ANZC2205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/14/2015
• 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: 66 YR