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

Catalog Number FEM10120

Device Problems Break (1069); Difficult or Delayed Positioning (1157); Fracture (1260); Malposition of Device (2616); Activation, Positioning or Separation Problem (2906)

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

Event Date 02/09/2016

Event Type  Injury  

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 further patient details.

Event Description

It was reported that during deployment of the endovascular stent graft in a dialysis case, the outer catheter snapped.The stent graft could be deployed with much effort by using hemostats.Due to the deployment difficulties, the stent graft was not deployed in the correct position at the target site and therefore, a second stent graft was used to cover the lesion completely.No patient injury was reported.

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 condition of the returned device, the reported deployment issue could be confirmed.The outer catheter was found to be elongated indicating the presence of high deployment force.The system was found to be fractured distal to the handle.Reportedly, the stent graft could be successfully implanted.As no images were provided, the reported malposition of the stent graft could not be verified.Potential contributing factors to the reported event have been considered.Previous investigations of similar complaints have been reviewed.The event may be associated with difficult anatomic conditions leading to increased friction during deployment and subsequent sheath fracture.Insufficient flushing of the device may be another contributing factor to the reported event.On the basis of the information available, a definite root cause for the reported event could not be determined.The ifu states that the device must be flushed with sterile saline.Also the ifu states: "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" and "do not kink the delivery catheter or use excessive force during delivery to the target lesion." furthermore, 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." and "examine the packaging and endovascular system to determine if there is any damage, defects or if the sterile barrier is compromised.Do not use the device if any of these conditions are observed.".

• 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: 5488435
• MDR Text Key: 39934761
• Report Number: 9681442-2016-00071
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 04049519008622
• UDI-Public: (01)04049519008622(17)180612(10)ANZF1436
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130029/S003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/12/2018
• Device Catalogue Number: FEM10120
• Device Lot Number: ANZF1436
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/29/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/10/2016
• Initial Date FDA Received: 03/09/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/11/2016
• 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 Outcome(s): Required Intervention
• Patient Age: 50 YR
• Patient Weight: 75