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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Headache (1880); Pain (1994); Rupture (2208)

Event Type  Injury  

Manufacturer Narrative

As the lot number of the subject device was not provided, a device history record review could not be performed.No sample or image was provided for evaluation.On the basis of the limited information available, the reported event could not be reproduced and a definitive root cause could not be determined.The instructions for use (ifu) which are applicable for this product were reviewed and it was found that the potential risks were sufficiently addressed.As stated in the ifu the complications and adverse events associated with the use of the fluency plus endovascular stent graft may include the usual complications associated with endovascular stent and stent graft placement and dialysis shunt revisions which include pain, vessel rupture and steal syndrome.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 or unwilling to provide any further patient, product, or procedural details to bard.

Event Description

It was reported that a patient had a 10 mm endovascular stent graft placed and during the stenting procedure, the vessel allegedly ruptured.Reportedly, the patient suffered from headaches, pain and steal syndrome.

• 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: 5769495
• MDR Text Key: 48767164
• Report Number: 9681442-2016-00185
• 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: consumer
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 06/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other