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

Catalog Number FVL06080

Device Problems Fracture (1260); Misfire (2532)

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

Event Date 10/14/2021

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 record is currently being performed.The return of the sample is pending.However, a video was provided for review.The investigation of the reported event is currently underway.(expiry date: 01/2023).

Event Description

It was reported that during a stent graft procedure, the stent allegedly fractured.It was further reported that stent partially deployed.There was no reported patient injury.

Event Description

It was reported that during a stent graft procedure via femoral access, the stent allegedly fractured.It was further reported that stent partially deployed.There was no reported patient injury.

Manufacturer Narrative

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.Manufacturing review: the lot history record of this lot was 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 physical device was not returned for evaluation.A video was sent by the costumer which shows that the outer sheath is fractured and the stent graft partially deployed.Therefore, the reported sheath fracture is confirmed as the main issue to the reported event which caused the stent graft to only partially deploy.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 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 graft deployment.' regarding the anatomy of the placement site the instructions for use states: 'prior to stent graft graft deployment, ensure that the proximal stent graft 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: '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 8f and a 0.035" guidewire.D4 (expiry date: 01/2023).H11: section a through f - the information provided by bd represents all of 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.

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: the lot history record of this lot was 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 physical device was returned for evaluation and a video was provided for review.The vessel was reported to be calcified.The system was reported to be flushed from both ports, and appropriate accessories were used.Additionally, the proximal end of the stent graft was placed in a straight section of the lumen prior to deployment.Based on the provided information, the investigation is confirmed for sheath fracture as the main issue and partial deployment as cascading event.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 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 graft deployment.' regarding the anatomy of the placement site the instructions for use states: 'prior to stent graft graft deployment (.), ensure that the proximal stent graft 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: '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 8f and a 0.035" guidewire.H10: d4 (expiry date: 01/2023), g3, h2.H11: h6 (method).H11: section a through f - the information provided by bd represents all of 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 : see h10.

Event Description

It was reported that during a stent graft procedure via femoral access, the stent allegedly fractured.It was further reported that stent partially deployed.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: 12841722
• MDR Text Key: 281600250
• Report Number: 9681442-2021-00597
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00801741144974
• UDI-Public: (01)00801741144974
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/03/2022

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: FVL06080
• Device Lot Number: ANEN0557
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2022
• Initial Date Manufacturer Received: 10/25/2021
• Initial Date FDA Received: 11/19/2021
• Supplement Dates Manufacturer Received: 01/17/2022; 02/03/2022
• Supplement Dates FDA Received: 01/19/2022; 02/08/2022
• 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