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

Catalog Number FVL14120

Device Problems Fracture (1260); Misfire (2532)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/09/2018

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 catalog number identified in section d4 has not been cleared in the us, but is similar to the fluency plus endovascular stent graft products that are cleared in the us.The pro code and 510 k number for the fluency plus endovascular stent graft products are identified respectively.

Event Description

It was reported that during a vascular stent graft placement procedure the outer catheter sheath allegedly fractured during an attempt to deploy the stent graft.There was no reported patient injury.

Event Description

It was reported that during a vascular stent graft placement in the external iliac artery via a left iliac artery access, the outer catheter sheath allegedly fractured during an attempt to deploy the stent graft.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: stent graft delivery system was returned for evaluation.The reported impossibility to deploy the stent graft was confirmed.The stent graft was found only partially deployed upon sample receipt.The condition of the delivery system, in particular the fractured and elongated outer sheath, indicates that increased deployment forces occurred during the attempt to deploy the stent graft.No manufacturing related issue could be confirmed.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 supplied with this product it was found that the instructions for use (ifu) sufficiently address the potential risks.Regarding preparation of the device the ifu states that "prior to loading the vascular system over a guide wire, both ports must be flushed with sterile saline.Flushing these lumens will also facilitate stent graft deployment." and "a super stiff guide wire (0.035 in.) is advanced from a femoral artery puncture site.Use an introducer sheath for the implant procedure." regarding the anatomy of the placement site the ifu states: "prior to stent graft deployment, ensure that the proximal stent graft end is positioned in a straight section of the lumen to reduce the risk of increased deployment forces and possible failure to deploy." (b)(4).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.

• Brand Name: FLUENCY PLUS VASCULAR STENT GRAFT
• Type of Device: VASCULAR STENT GRAFT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 7862447
• MDR Text Key: 119811362
• Report Number: 9681442-2018-00167
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00801741145377
• UDI-Public: (01)00801741145377
• Combination Product (y/n): N
• PMA/PMN Number: P130029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 11/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/30/2021
• Device Catalogue Number: FVL14120
• Device Lot Number: ANCS1464
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2018
• Date Manufacturer Received: 11/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 85