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

Catalog Number FVM12120

Device Problems Entrapment of Device (1212); Detachment of Device or Device Component (2907)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/12/2021

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.However, an image was provided for review.The investigation of the reported event is currently underway.The catalog number identified 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: 06/2022).Device pending return.

Event Description

It was reported that during a stent placement procedure, the graft was stuck in the metaling ring which then tore from the delivery system.It was further reported that the patient undergo surgery and have the metal ring removed.The patient status was unknown.

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 returned for evaluation.Based on the investigation of the returned delivery system and the provided x-ray, a tip break and detachment were confirmed.The sample was returned in used condition without sent graft which indicated that the sent graft had been deployed, as reported.The outer sheath was found elongated, and the distal tip was part of the sample return.In this case the tracking vessel was not calcified.System compatible guide and sheath were being used, and the system was flushed.Based on the information available, a definite root cause for the reported event could not be determined.Labeling review: in reviewing the labeling supplied with this product it was found that the instructions for use sufficiently address the potential risks.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 sent graft deployment.' the instructions for use 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 instructions for use further state: 'ensure that the proximal sent 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 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" guide.H10:d4 (expiry date: 06/2022),.

Event Description

It was reported that during a stent placement procedure, the stent graft was stuck in the metaling ring which then tore from the delivery system.It was further reported that the patient undergo surgery and have the metal ring removed.The patient status was unknown.

• 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: 11788822
• MDR Text Key: 249446978
• Report Number: 9681442-2021-00298
• 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: 06/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: FVM12120
• Device Lot Number: ANDT2854
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2021
• Initial Date Manufacturer Received: 04/12/2021
• Initial Date FDA Received: 05/07/2021
• Supplement Dates Manufacturer Received: 06/08/2021
• Supplement Dates FDA Received: 06/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention