MAUDE Adverse Event Report: ANGIOMED GMBH & CO. MEDIZINTECHNIK KG COVERA VASCULAR COVERED STENT

Model Number AVFM10100

Device Problems Break (1069); Misfire (2532)

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

Event Date 05/08/2023

Event Type  malfunction  

Event Description

It was reported that during a stent graft placement procedure in left basilic vein via left upper arm, when started to deploy the stent using the large pinwheel, the pinwheel became stuck and the stent allegedly stopped deployment about half way.It was further reported that the stent was allegedly partially deployed of approximately 10-20mm.Reportedly the stent was removed.There was no reported patient injury.

Manufacturer Narrative

H10: 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.However, a photo and a video were provided for review.The investigation of the reported event is currently underway.H10: d4 (expiry date: 06/2024).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.

Manufacturer Narrative

H10: manufacturing review: 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.Based on the information available it is not reasonably suggested that a manufacturing process may have caused or contributed to the reported issue.Investigation summary: the delivery system was returned for evaluation and the covered stent was found partially deployed; the force transmitting proximal sheath was broken which indicates high tensile forces were experienced during deployment.It is considered the break of the proximal sheath led to the impossibility to deploy the stent which leads to confirmed results for break and failure to deploy.Also, the provided photo and movie show the covered stent partially deployed.It was reported that the device was flushed, a 7f introducer/0.035" guidewire were used, pre-dilation was performed, the device was placed in the straight section of the lumen before deployment attempts and there was no tortuosity or calcification of the vessel.Based on available information and evaluation of the returned sample, the investigation is closed with confirmed results for break and failure to deploy.A definite root cause for the reported event could not be found.Labeling review: in reviewing the relevant labeling for this product, the potential issue was found addressed.Based on the instructions for use supplied with this product delivery system specific events that could be associated with clinical complications include but are not limited to partial deployment and high deployment forces.With regards to accessories, the instructions for use states, use "0.035 inch guidewire of appropriate length to allow safe delivery of the covered stent and removal of the delivery system.Introducer sheath with appropriate inner diameter and length".Holding the device during deployment is found sufficiently described in the instructions for use.Regarding preparation the instructions for use states: "pre-dilate the stenosis with a pta balloon catheter of appropriate length and diameter for the lesion to be treated".H10: d4 (expiration date: 06/2024), g3 h11: h6 (result, conclusion) h11: section a through f ¿ the information provided 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.H3 other text : see h10.

Event Description

It was reported that during a stent graft placement procedure in left basilic vein via left upper arm, when started to deploy the stent using the large pinwheel, the pinwheel became stuck and the stent allegedly stopped deployment about half way.It was further reported that the stent was allegedly partially deployed of approximately 10-20mm.Reportedly, the stent was removed.There was no reported patient injury.

• Brand Name: COVERA VASCULAR COVERED STENT
• Type of Device: VASCULAR COVERED STENT
• 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: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 17048696
• MDR Text Key: 316419068
• Report Number: 9681442-2023-00212
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00801741106613
• UDI-Public: (01)00801741106613
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P170042
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AVFM10100
• Device Catalogue Number: AVFM10100
• Device Lot Number: ANGT0762
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/13/2023
• 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