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

Catalog Number FVL10120

Device Problems Fracture (1260); Device Damaged Prior to Use (2284)

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

Event Date 03/12/2021

Event Type  malfunction  

Manufacturer Narrative

Manufacturing review: a review of manufacturing records was not performed, as additional complaints have not been reported for this lot.Based on the information available it is not reasonably suggested that a manufacturing process may have caused or contributed to the reported issue.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 returned for evaluation.Based on the investigation performed in the laboratory, a 'device damaged prior to use' could not be confirmed as the device was found used and fractured on the outer sheath and the stent was found with coagulated blood.It is recommended to inspect the device prior to use for any damage or defect.However, the sample was found in used condition and the sheath was found fracture which indicates the excessive force which was applied to the system.An attempt was made to clarify the condition of the sample which was conflicting from what it was reported; however only the blood issue was referenced.Therefore, the investigation was conducted based on the findings in the laboratory which indicates the excessive force on the system which result to sheath fracture.Additionally, stent graft was found within the system; however, a 'failure to deploy' cannot be confirmed, since limited information was provided.Therefore, the investigation for the reported device damaged prior to use is inconclusive and the alleged fracture was confirmed.Based on the information available a definite root cause for the reported event could not be determined.Labeling review: in reviewing the relevant labeling it was found that the instructions for use sufficiently address the potential risks.Regarding the preparation of the device the instructions for use states 'carefully remove the delivery system from its packaging and inspect for any damage or defects.Do not use if a compromise to the sterile barrier is suspected'.However, the returned device was received bloody which indicates that the system was in used.Regarding preparation of the device the instructions for use 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.' 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.' regarding 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.(expiry date: 03/2022).The catalog number identified has not been cleared in the us but is similar to the fluency plus endovascular stent graft that are cleared in the us.The pro code and 510 k number for the fluency plus endovascular stent graft.

Event Description

It was reported that prior to a stent placement procedure in an iliac artery, the safety clip was allegedly found to be opened.The device was replaced with another one to complete the procedure.There was no patient contact.

• Brand Name: FLUENCY PLUS VASCULAR STENT GRAFT
• Type of Device: VASCULAR STENT GRAFT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstr. 6; karlsruhe 76227 ; GM 76227
• Manufacturer (Section G): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstr. 6; karlsruhe 76227 ; GM 76227
• Manufacturer Contact: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 12412492
• MDR Text Key: 269547835
• Report Number: 9681442-2021-00482
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00801741145254
• UDI-Public: (01)00801741145254
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P130029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: FVL10120
• Device Lot Number: ANDQ2636
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/05/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 27 YR
• Patient Weight: 52