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

Catalog Number FEM14060

Device Problem Positioning Failure (1158)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/16/2015

Event Type  malfunction  

Event Description

It was reported that during deployment, the endovascular stent graft could not be deployed any further after being partially released.The partially released stent graft could be pulled back into the sheath and another stent graft was used to complete the procedure successfully.

Manufacturer Narrative

The device history records are being reviewed.The event is currently under investigation.Despite good faith efforts to obtain additional information, the complainant was unable or unwilling to provide any patient details.

• 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: 4692978
• MDR Text Key: 5647809
• Report Number: 9681442-2015-00029
• 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: Physician
• Type of Report: Initial
• Report Date: 03/16/2015

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 Expiration Date: 07/11/2017
• Device Catalogue Number: FEM14060
• Device Lot Number: ANYG1274
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/30/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/16/2015
• Initial Date FDA Received: 04/13/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2014
• 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