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

Catalog Number FVM08040

Device Problems Difficult or Delayed Positioning (1157); Fracture (1260); Retraction Problem (1536)

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

Event Date 01/29/2021

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history record is currently being performed.The device has not been returned to the manufacturer for evaluation.However, photos were provided for review.The investigation of the reported event is currently underway.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 510 k number for the fluency plus endovascular stent graft products are identified.(expiry date: 10/2022).

Event Description

It was reported that during stent placement procedure, the outer sheath of the stent allegedly could not be withdrawn after multiple attempts.The procedure was completed using another device.There was no reported patient injury.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 products that are cleared in the us.The pro code and 510 k number for the fluency plus endovascular stent graft products 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 available for evaluation.Based on the provided images, sheath fracture can be confirmed.In this case the system was flushed but the product was used off label.Based on the information available, the investigation is closed with confirmed result.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 sufficiently address the potential factors.Regarding preparation the instructions for use states: 'prior to loading the delivery system over a guide wire, both ports must be flushed with sterile saline (.).Flushing these lumens will also facilitate stent graft deployment.' furthermore, 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.' the product is indicated for use in the iliac and femoral arteries.H10: d4 (expiry date: 10/2022), g3.H11: h6 (device, method, result, conclusion).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.

Event Description

It was reported that during stent placement procedure, the stent allegedly difficult to deploy.The procedure was completed using another device.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
• MDR Report Key: 11377400
• MDR Text Key: 245117721
• Report Number: 9681442-2021-00065
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 05/12/2021

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: FVM08040
• Device Lot Number: ANDX5083
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/29/2021
• Initial Date FDA Received: 02/25/2021
• Supplement Dates Manufacturer Received: 06/14/2021
• Supplement Dates FDA Received: 06/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 73 YR
• Patient Weight: 55