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

Model Number AVFM10060

Device Problems Obstruction of Flow (2423); Material Deformation (2976)

Patient Problems Pain (1994); Swelling/ Edema (4577)

Event Date 09/01/2021

Event Type  Injury  

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, a image was provided for review.The investigation of the reported event is currently underway.(expiry date: 10/2022).Device not returned.

Event Description

It was reported that a few days post stent placement procedure in the lue av fistula, blood flow was allegedly noted to be obstructed.It was further reported that the patient's upper arm was red, swollen and was painful.Upon examination, the stent was found to be collapsed.The current status of the patient is unknown.

Event Description

It was reported that a few days post stent placement procedure in the lue av fistula, blood flow was allegedly noted to be obstructed.It was further reported that the patient's upper arm was red, swollen and was painful.Upon examination, the stent was found to be collapsed.The current status of the patient is unknown.

Manufacturer Narrative

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 returned for evaluation.Provided images demonstrate the placed covered stent inside patient in a curved section.On the inner side of the curved section the covered stent appears deformed but open leading to decrease of patency, which leads to confirmed result for stent deformation.A closer description was not possible due to poor resolution.The lesion was pre dilated, and the stent was placed in a curved section.The definitive root cause could not be determined based upon available information.Labeling review: in reviewing the relevant labeling for this product, the potential issue was found addressed.The instructions for use state: 'special care must be taken to ensure that an appropriately sized device is selected.In the case of a diameter difference between the inflow and the outflow end, utilize the following as the reference vessel depending on the type of access.For an av graft access, utilize the graft diameter and for an av fistula access, utilize the inflow vein diameter.' a covered stent diameter selection table is part of the instructions for use demonstrating the relationship between covered stent diameter, and recommended oversizing.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.', and 'post dilate the covered stent with an angioplasty balloon sized appropriately as to ensure complete wall apposition to the reference vessel.' under covered stent specific events that could be associated with clinical complications the instructions for use mention: '(¿), compression, kinking and insufficient covered stent expansion.' 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.

• 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: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 12555449
• MDR Text Key: 274241321
• Report Number: 9681442-2021-00529
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00801741106590
• UDI-Public: (01)00801741106590
• 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: 02/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AVFM10060
• Device Catalogue Number: AVFM10060
• Device Lot Number: ANEX1676
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other
• Patient Sex: Female