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

Catalog Number FVM14040

Device Problems Break (1069); Migration or Expulsion of Device (1395); Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/19/2019

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.The catalog number identified has not been cleared in the u.S.But, it is similar to the fluency plus endovascular stent graft products that are cleared in the us.The 510 k number and pro code for the fluency plus endovascular stent graft products are identified.(expiry date: 09/2022).

Event Description

It was reported that post stent graft placement in the superior vena cava via right basilic vein, the ring at the tip of the delivery system detached and migrated to a small branch of the pulmonary artery.It was further reported that unsuccessful attempts were made to recover the fragment with a lasso; the device fragment currently remains in the patient.No clinical consequences were reported.

Manufacturer Narrative

H10: 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.Investigation summary: based on the investigation of the returned catheter sample a tip break was confirmed.The sample was returned in used condition without stent graft which indicated that the stent graft had been deployed, as reported.The outer sheath was found broken proximal of the marker, and the distal tip was not part of the sample return.It was assumed that the tip broke as a consequence of interaction with the stent graft during deployment.As a result of the investigation the complaint is confirmed.A definite root cause for the reported event could not be determined.The reported application represents an off label use of the device.Labeling review: based on the lot number reported, the following instructions for use (ifu) were supplied with the product: in reviewing the 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 state 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.' the ifu further states: '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.' the ifu further state: '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.' regarding accessories the ifu state: 'use an introducer sheath for the implant procedure.', and 'the catheter tip is tapered to accommodate a 0.035 in.Guide wire.'; the packaging labels indicate the use of a 10f introducer size and a 0.035" guidewire.The product is indicated for use in the iliac and femoral arteries.The catalog number identified in section d4 has not been cleared in the u.S.But, it is similar to the fluency plus endovascular stent graft products that are cleared in the us.The 510 k number and pro code for the fluency plus endovascular stent graft products are identified in d2 and g5.H10: b5, d4(expiry date: 09/2022), g4.H11: d10, h3, h6(methods, results, conclusion).H11:section a through f - the information provided by bd 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 bd.

Event Description

It was reported that post stent graft placement in the superior vena cava via right basilic vein, the ring at the tip of the delivery system broke, detached, and moved into a small branch of the pulmonary artery.It was further reported that unsuccessful attempts were made to recover the fragment with a lasso; the device fragment currently remains in the patient.No clinical consequences were reported.

• 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: 9599210
• MDR Text Key: 177153656
• Report Number: 9681442-2019-00260
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00801741145858
• UDI-Public: (01)00801741145858
• 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: 03/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: FVM14040
• Device Lot Number: ANDW4268
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2020
• Date Manufacturer Received: 03/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other