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

Catalog Number FEM09060

Device Problems Positioning Failure (1158); Fracture (1260)

Patient Problems Death (1802); No Consequences Or Impact To Patient (2199)

Event Date 04/12/2015

Event Type  Death  

Event Description

It was reported that during re-stenting of the portal vein in a tips revision procedure with several stent grafts, one stent graft could not be deployed any further after being partially released.The system could be retracted without issues.The tips procedure was successfully completed with several stent grafts.The pt expired later.As assessed by the physician, the death of the pt is not related to the malfunction of the device.

Manufacturer Narrative

The device history records are being reviewed.The event is currently under investigation.The info provided by bard represents all of the known info at this time.Despite good faith efforts to obtain additional info, the complainant was unable to provide any further pt details.

Manufacturer Narrative

During a retrospective review the mdr classification has been reassessed.It was reported that a tips revision was successfully completed and bleeding was reduced but the patient expired later that evening.Even if the physician assessed that the death of the patient is not related to the malfunction of the device this complaint will be conservatively converted into a death report.Several unsuccessful attempts were made to receive medical records, i.E.The autopsy report.Based on the information available it cannot be definitely excluded that the device issue contributed to the patients' death.Included udi code.Additional info: adverse event and/or product problem, outcomes attributed to adverse events, type of reportable event, model #/lot #.

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.The evaluation of the returned sample confirmed the partial release of the stent graft.The outer sheath of the delivery system was found to be torn off.The condition of the device indicates that high friction forces affected on the system resulting in deployment difficulties and outer sheath fracture.Potential contributing factors to the reported event have been considered.Previous investigations of similar complaints have been reviewed.This type of event may be associated with a difficult vessel anatomy leading to increased friction and subsequent deployment failure.In this case, the tracking path was tortuous.The re-stenting of the portal vein in a tips revision procedure represents an off-label use of the device which may have contributed to the reported event.Based on the information available, a definite root cause could not be determined.

• Brand Name: FLUENCY PLUS ENDOVASCULAR STENT GRAFT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; karlsruhe ; GM
• Manufacturer (Section G): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• Manufacturer Contact: daniela mueller ; wachhausstrasse 6; karlsruhe 76227 ; GM 76227 ; 2194450
• MDR Report Key: 4787297
• MDR Text Key: 20730123
• Report Number: 9681442-2015-00045
• 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: Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/22/2017
• Device Catalogue Number: FEM09060
• Device Lot Number: ANYG2967
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/06/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2014
• 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): Death
• Patient Age: 56 YR