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

Catalog Number UNK FLUENCYPLUS VASC STNT GRFT

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

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 05/24/2017

Event Type  Injury  

Event Description

It was reported that one day post stent placement in the left iliac artery to treat an aneurysm, the patient had an adverse event of bleeding and endoleak type 'ia'.No re-intervention was required to treat the bleeding and the endoleaks.The event was assessed as being likely related to the device.The current status of the patient is unknown.

Manufacturer Narrative

The catalog number identified has not been cleared in the us but is similar to the fluency plus endovascular stent graft products that are cleared in the us.The pro code and 510 k number for the fluency plus endovascular stent graft products are identified.Manufacturing review: the device history record review could not be performed since the lot number of the device was not provided.Investigation summary: the sample was not returned for evaluation and image was not provided for review.In this case, a postoperative bleeding was identified.The provided information is limited and it is not known where the bleeding occurred.Based on the information available a potential relation to the device or a potential device deficiency could not be verified.The device was used off-label; however, there is no evidence that may relate the off-label use with the reported event.Therefore, the investigation is inconclusive for the reported issue.The definitive root cause could not be determined based upon available information.Labeling review: in reviewing the relevant labeling, it was found that the instructions for use sufficiently address the potential risks.Regarding the potential complications, which may occur during or after the implantation of the stent graft, the instructions for use includes: bleeding at the site of catheter placement, distal embolization, trauma to the vessel wall, vessel rupture, among others.The reported use of the device for treatment of an aneurysm represents an off label use.Based on the labeling supplied with this product the instructions for use states: "the safety and effectiveness of the device for use in the treatment of aneurysms and pseudoaneurysms have not been established.".

• Brand Name: FLUENCY PLUS VASCULAR STENT GRAFT
• Type of Device: VASCULAR STENT GRAFT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstr. 6; karlsruhe 76227 ; GM 76227
• Manufacturer (Section G): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstr. 6; karlsruhe 76227 ; GM 76227
• Manufacturer Contact: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 13470203
• MDR Text Key: 285148718
• Report Number: 9681442-2022-00022
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P130029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK FLUENCYPLUS VASC STNT GRFT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2022
• 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