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

Catalog Number FVL08040

Device Problem Malposition of Device (2616)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/13/2020

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was not provided, a review of the device history records could not 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.

Event Description

It was reported that during a stent placement, the device allegedly mal-positioned in the aorta.There was no reported patient injury.

Event Description

It was reported that during a stent placement, the device allegedly mal-positioned in the aorta.There was no reported patient injury.

Manufacturer Narrative

H10: the fda rn number for the intial mdr was inadvertently submitted as (b)(4).The correct fda rn number was (b)(4).H10: 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 510k number for the fluency plus endovascular stent graft products is identified in d2 and g5.H10: manufacturing review: a review of manufacturing records was not performed, as additional complaints have not been reported for this lot, previously.However, the lot history records of this lot were 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.Investigation summary: the sample was not returned for evaluation.The investigation is closed with inconclusive result.A definite root cause for the reported event could not be determined.Labeling review: iin reviewing the relevant labeling it was found that the instructions for use sufficiently address the potential risks.Regarding preparation of the device the instructions for use 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.' regarding the anatomy of the placement site the instructions for use 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.' in regards to accessories the instructions for use 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'; the packaging pictograms indicate an introducer size of 9f and a 0.035" guidewire.H10: d4 (expiry date: 07/2022), g4.H11: b3, d1, d4, e1, h6(method).H11: section a through f: the information provide by bd represents all 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.H3 other text : device not returned.

• Brand Name: FLUENCY PLUS VASCULAR STENT GRAFT
• Type of Device: VASCULAR STENT GRAFT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstr. 6; karlsruhe AZ 76227 ; GM 76227
• MDR Report Key: 11018327
• MDR Text Key: 221752008
• Report Number: 2020394-2020-20846
• Device Sequence Number: 1
• Product Code: PFV
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 01/25/2021

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 Catalogue Number: FVL08040
• Device Lot Number: ANDU1792
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/19/2020
• Initial Date FDA Received: 12/16/2020
• Supplement Dates Manufacturer Received: 01/25/2021
• Supplement Dates FDA Received: 02/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other