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

Catalog Number FVL14120

Device Problems Difficult or Delayed Positioning (1157); Misfire (2532); Malposition of Device (2616)

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

Event Date 07/13/2021

Event Type  malfunction  

Manufacturer Narrative

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 are identified.As the lot number for the device was provided, a review of the device history records 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.(expiry date: 02/2024).Device not returned.

Event Description

It was reported that during a stent graft placement procedure, the stent was allegedly difficult to deploy.It was further reported that the stent was pulled out when it was partially deployed and the stent missed the intended deployment site and got malpositioned.Another stent was used to the extent the mispositioned stent.There was no reported patient injury.

Manufacturer Narrative

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 that are cleared in the us.The pro code and 510 k number for the fluency plus endovascular stent graft are identified in d2 and g4.H10: 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 not returned for evaluation and image was not provided.Therefore, the investigation is inconclusive for the reported issue.A definitive root cause could not be determined based upon the available information.Labeling review: in reviewing the relevant labeling it was found that the instructions for use sufficiently address the potential risks.The instructions for use states "prior to stent graft deployment in tortuous anatomy, 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 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." the packaging pictograms indicate an introducer size of 10f and a 0.035" guidewire.Regarding the precautions the instructions for use states: 'higher deployment force may be encountered on longer length stent graft.' h10: d4 (expiry date: 02/2024).Device not returned.

Event Description

It was reported that during a stent graft placement procedure, the stent was allegedly difficult to deploy.It was further reported that the stent was pulled out when it was partially deployed and the stent missed the intended deployment site and got malpositioned.Another stent was used to the extent the mispositioned stent.There was no reported patient injury.

• 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: 12299170
• MDR Text Key: 265795087
• Report Number: 9681442-2021-00434
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: P130029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/03/2021

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: FVL14120
• Device Lot Number: ANFP0734
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/16/2021
• Initial Date FDA Received: 08/10/2021
• Supplement Dates Manufacturer Received: 12/03/2021
• Supplement Dates FDA Received: 12/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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