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

Catalog Number FVL08080

Device Problems Break (1069); Material Perforation (2205); Malposition of Device (2616); Activation Failure (3270)

Patient Problems Aneurysm (1708); Great Vessel Perforation (2152)

Event Date 01/12/2018

Event Type  Injury  

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 has been returned for evaluation.The investigation is currently underway.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 placement of the vascular stent graft in the common iliac artery alleged excessive force was experienced during deployment causing the stent graft to deploy in an alleged unintended location.It was also reported that the stent graft allegedly failed to expand as it deployed; therefore, the health care provider attempted to reposition the stent graft; causing the stent to begin expanding in the wrong location.Reportedly, the delivery system was removed and upon removal the shaft was identified allegedly damaged in one place.An additional manufacturer's stent graft was used for treatment.Angio-seal was reportedly used to close the vessel.Furthermore, the patient experienced an alleged consecutive aneurysm.Current patient status was not provided.

Event Description

It was reported that during placement of the vascular stent graft in the common iliac artery alleged excessive force was experienced during deployment causing the stent graft to deploy in an alleged unintended location.It was also reported that the stent graft allegedly failed to expand as it deployed; therefore, the health care provider attempted to reposition the stent graft; causing the stent to begin expanding in the wrong location.Reportedly, the delivery system was removed and upon removal the shaft was identified allegedly damaged in one place.An additional manufacturer's stent graft was used for treatment.Angio-seal was reportedly used to close the vessel.Furthermore, the patient experienced an alleged consecutive aneurysm.Current patient status was not provided.

Manufacturer Narrative

Manufacturing review: the lot number was provided and the lot device history records have been reviewed.The lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint that has been reported for this corporate lot number to date.Investigation summary: based on the investigation of the returned physical sample it was confirmed that excessive release force was present and that the stent graft could only be partially deployed.During evaluation it was found that the stent graft perforated the delivery system tip which led to stent graft deformation, force increase, outer sheath fracture, and subsequent deployment failure.Images have not been provided so that an evaluation of the alleged malexpansion, malpositioning, and aneurysm formation was not possible.However, the deformation of the stent graft led to an increased outer dimension which may have led to the alleged vessel injury upon removal.Therefore, as a result of the investigation performed the complaint was confirmed.However, based on the available information and the evaluation of the returned sample, a definite root cause for the reported event could not be determined.Labeling review: in reviewing the relevant labeling for this product it was found that the instructions for use (ifu) sufficiently address the potential risks.Regarding preparation of the device and the patient anatomy 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 '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.' furthermore, the ifu states: 'a super stiff guide wire (0.035 in.) is advanced from a femoral artery puncture site.Use an introducer sheath for the implant procedure.', and 'the sterile packaging and devices should be inspected prior to use.Verify that the packaging and the device are undamaged and that the sterile barrier is intact.If damaged, do not use.'.

• 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: 7306885
• MDR Text Key: 101297103
• Report Number: 9681442-2018-00027
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00801741145346
• UDI-Public: (01)00801741145346
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 04/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2020
• Device Catalogue Number: FVL08080
• Device Lot Number: ANBP3457
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2018
• Date Manufacturer Received: 04/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 90 YR
• Patient Weight: 75