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

Catalog Number FEM09100

Device Problems Positioning Failure (1158); Material Perforation (2205)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 04/19/2016

Event Type  malfunction  

Manufacturer Narrative

The device history records are being reviewed.The event is currently under investigation.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 to provide any further patient or procedural details.

Event Description

It was reported that the endovascular stent graft could not be deployed.Another endovascular stent graft was used to complete the procedure successfully.No complications were caused.There was no reported patient injury.

Manufacturer Narrative

The lot history records have been reviewed with special attention to the manufacturing and inspection of this product and the product was found to have met all specifications prior to shipment.There is no indication for a manufacturing-related failure.On the basis of the evaluation of the returned device, the reported deployment failure could be confirmed.A stent graft strut was found to have perforated the distal outer sheath of the delivery system causing the impossibility to deploy the stent graft.Potential contributing factors to the reported event have been considered.Previous investigations of similar complaints have been reviewed.The evaluation of the device revealed that the stent graft could not be deployed due to a strut perforating the distal outer sheath of the delivery system.This may be associated with difficult anatomic conditions or a challenging placement site leading to increased friction and subsequent deployment difficulties.Also not using an introducer sheath or the use of an inappropriately sized guide wire may contribute to a tip damage and subsequent perforation.Insufficient flushing of the device may be another contributing factor to increased friction and subsequent device damage.On the basis of the information available, a definite root cause for the reported event could not be determined.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 of the same size." and "the safety and effectiveness of the device when placed across a tight bend (.) has not been evaluated.Prior to stent graft deployment, ensure that the proximal (inflow) stent graft end is positioned in a straight section of the lumen to reduce the risk of higher deployment forces and possible endovascular system failure." the ifu indicates that a 0.035" (0.89 mm) guide wire and an introducer sheath with appropriate inner diameter are required for the procedure.Furthermore, the ifu states that the device must be flushed with sterile saline.

• 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: 5665292
• MDR Text Key: 46695957
• Report Number: 9681442-2016-00133
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 04049519008561
• UDI-Public: (01)04049519008561(17)180612(10)ANZF1362
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130029/S002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/12/2018
• Device Catalogue Number: FEM09100
• Device Lot Number: ANZF1362
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2015
• 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 Age: 43 YR
• Patient Weight: 90