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

Model Number FEM12080

Device Problems Bent (1059); Entrapment of Device (1212); Material Perforation (2205); Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

No medical records were provided to the manufacturer.An image was provided.The lot number for the device was provided.The device history records and image are currently under review.The return of the device is pending.The investigation is currently under way.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 during deployment of a vascular stent graft via an upper left arm access into a brachial cephalic fistula without an introducer sheath, the stent graft allegedly got caught on an existing stent and one of the struts was bent backwards.The stent graft was removed without incident.Reportedly, another stent was used to complete the procedure.There was no reported patient injury.

Event Description

It was reported that during deployment of a vascular stent graft via an upper left arm access into a brachial cephalic fistula without an introducer sheath, the stent graft allegedly got caught on an existing stent and one of the struts was bent backwards.The stent graft was removed without incident.Reportedly, another stent was used to complete the procedure.There was no reported patient injury.

Manufacturer Narrative

H10: manufacturing review: 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.No additional complaint has been reported for this lot number previously.Investigation summary: based on the investigation of the provided image it was confirmed that the user tried to deploy the stent graft which was not successful because one stent graft strut perforated the outer catheter wall.X-ray images have not been provided so that entrapment could not be confirmed.An indication for a process related issue could not be identified.As a result of the investigation performed the complaint is confirmed for stent strut perforation.A definite root cause for the reported event could not be determined.Labeling review: in reviewing the labeling supplied with this product 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.' regarding the use of accessories the ifu states: 'materials required for the fluency plus endovascular stent graft procedure: introducer sheath with appropriate inner diameter.H10: g4; d4 expiry date: june / 2020.

• 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: 7589854
• MDR Text Key: 110709440
• Report Number: 9681442-2018-00090
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 04049519008653
• UDI-Public: (01)04049519008653
• 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: 07/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FEM12080
• Device Catalogue Number: FEM12080
• Device Lot Number: ANBT1910
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/15/2018
• Initial Date FDA Received: 06/11/2018
• Supplement Dates Manufacturer Received: 07/06/2018
• Supplement Dates FDA Received: 07/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 66 YR