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

Catalog Number FEM14040

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Information (3190)

Event Date 01/09/2015

Event Type  Injury  

Event Description

It was reported that the endovascular stent graft migrated following deployment.Therefore, the deployment system was exchanged for a pta balloon which was inflated in an attempt to capture the stent graft and pull it back to the lesion site at the junction of left innominate vein and superior vena cava; however, the stent graft released from the balloon and migrated to the right atrium.The patient had been transferred from the outpatient treatment facility to hospital for surgical removal of the stent graft where it was successfully retrieved via femoral vein cut down.

Manufacturer Narrative

The lot number has been provided.The device history records are being reviewed.Additional information has been requested and images were received.The investigation is currently underway.

• Brand Name: FLUENCY PLUS ENDOVASCULAR STENT GRAFT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; karlsruhe ; GM
• Manufacturer (Section G): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 7622 7; GM 76227
• Manufacturer Contact: daniela mueller ; wachhausstrasse 6; karlsruhe 76227 ; GM 76227 ; 2194450
• MDR Report Key: 4449783
• MDR Text Key: 5428535
• Report Number: 9681442-2015-00005
• 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: Other
• Type of Report: Initial
• Report Date: 01/09/2015

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 Expiration Date: 04/29/2017
• Device Catalogue Number: FEM14040
• Device Lot Number: ANYD3794
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/09/2015
• Initial Date FDA Received: 01/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2014
• 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): Life Threatening; Required Intervention