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

Model Number FEL10120

Device Problems Positioning Failure (1158); Difficult to Remove (1528); Misfire (2532); Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/17/2018

Event Type  malfunction  

Manufacturer Narrative

No medical records and no medical images were provided to the manufacturer.The lot number for the device was provided.The device history records are currently under review.The device was returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.

Event Description

It was reported that after multiple attempts, the endovascular stent graft allegedly would not deploy in the left common iliac artery via a right common femoral artery access site.It was further reported that there was some difficulty advancing the delivery system to and retracting the delivery system from the target lesion.Reportedly, another stent was used to complete the procedure.There was no reported patient injury.

Event Description

It was reported that after multiple attempts, the endovascular stent graft allegedly would not deploy in the left common iliac artery via a right common femoral artery access site.It was further reported that there was some difficulty advancing the delivery system to and retracting the delivery system from the target lesion.Reportedly, another stent was used to complete the procedure.There was no reported patient injury.

Manufacturer Narrative

Manufacturing review: based on the information available and the investigation performed, there is no indication that the product failed to meet its specification prior to shipment.The lot records have been reviewed with special attention to the manufacturing and inspection of this product and the product was found to have met the specification prior to shipment.The review shows that no remarkable incidents occurred during the manufacturing process.No relevant manufacturing process changes were implemented, that could have led to the event reported.Investigation summary: on the basis of the returned stent graft delivery system, the alleged deployment issue could be confirmed.The outer sheath was found to be elongated which indicated that increased friction affected the delivery system during attempt of stent graft deployment and subsequently resulted in a partial stent graft deployment.The reported difficulties to advance and to retract the delivery system to the target lesion could not be reproduced.No indication was found for manufacturing related issues.Based on the information available and the evaluation of the sample returned, a definite root cause for the reported event could not be determined.Labeling review: in reviewing the current labeling it was found that the instructions for use (ifu) sufficiently address the potential risk.The ifu states: "if unusual resistance or high deployment force is encountered during stent graft deployment, abort the procedure, remove the delivery system and use an alternative device." furthermore, the ifu states: "prior to loading the endovascular system over a guide wire, both ports must be flushed with sterile saline (¿).Flushing these lumens will also facilitate stent graft deployment." regarding treatment of aneurysms the ifu states: "the safety and effectiveness of the device when placed across an aneurysm or a pseudoaneurysm has not been evaluated." (b)(4).

• 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
• MDR Report Key: 7895617
• MDR Text Key: 120966549
• Report Number: 9681442-2018-00173
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 04049519008271
• UDI-Public: (01)04049519008271
• Combination Product (y/n): N
• PMA/PMN Number: P130029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/13/2020
• Device Model Number: FEL10120
• Device Catalogue Number: FEL10120
• Device Lot Number: ANBR1726
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2018
• Date Manufacturer Received: 10/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 76