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

Catalog Number FVL06080

Device Problems Positioning Failure (1158); Fracture (1260)

Patient Problem Hematoma (1884)

Event Date 08/21/2017

Event Type  Injury  

Manufacturer Narrative

No medical records or no medical images have been made available to the manufacturer.As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.The information provided by bard 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 bard.

Event Description

It was reported that during a stent graft deployment procedure to treat a hematoma in the proximal end of the left superficial femoral artery by contralateral access through the right common femoral artery, the stent graft was allegedly unable to deploy.Reportedly, the tracking vessels were calcified and the iliac arteries were tortuous, however a stiff wire was used to avoid issues with advancing the stent graft into the target lesion.It was further reported that during stent graft deployment, resistance was felt which prompted the health care provider to forcibly attempt to deploy and resulted in the shaft to break.Furthermore, the prolonged procedure resulted in a larger hematoma than as it was originally, therefore medical intervention was required to treat the hematoma.Another device was used to complete the procedure.Current patient status unknown.

Manufacturer Narrative

Manufacturing review: the lot records have been 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.The review shows that no remarkable incidents occurred during the manufacturing process.No relevant manufacturing process changes were implemented, that could have led to the event reported.No additional complaint has been reported for this lot number previously.Investigation summary: on the basis of the returned stent graft delivery system, the alleged deployment failure could be confirmed.The outer sheath was found to be elongated, which indicated that a high deployment force was present during the deployment attempt, which subsequently resulted in an outer catheter fracture.Based on the information available and the evaluation of the sample returned, 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 (ifu) sufficiently address the potential risks.Regarding preparation of the device the ifu 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." regarding the anatomy of the placement site the ifu 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." (b)(4).

Event Description

It was reported that during a stent graft deployment procedure to treat a hematoma in the left proximal sfa by contralateral access through the right common femoral artery, the stent graft was allegedly unable to deploy.Reportedly, during stent graft deployment, resistance was felt which prompted the health care provider to forcibly attempt to deploy and resulted in the shaft to break.Furthermore, the prolonged procedure resulted in a larger hematoma than as it was originally, therefore medical intervention was required to treat the hematoma.Another device was used to complete the procedure.Current patient status unknown.

• Brand Name: FLUENCY PLUS VASCULAR STENT GRAFT
• Type of Device: VASCULAR STENT GRAFT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• Manufacturer (Section G): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• Manufacturer Contact: judith ludwig ; 1625 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 6901884
• MDR Text Key: 87723538
• Report Number: 9681442-2017-00274
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• Reporter Country Code: PL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/10/2017

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 Expiration Date: 04/30/2020
• Device Catalogue Number: FVL06080
• Device Lot Number: ANBR1722
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/04/2017
• Initial Date FDA Received: 09/28/2017
• Supplement Dates Manufacturer Received: 10/26/2017
• Supplement Dates FDA Received: 11/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/29/2017
• 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 Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 67