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

Catalog Number UNK COVERA

Device Problems Obstruction of Flow (2423); Activation Failure (3270)

Patient Problems No Consequences Or Impact To Patient (2199); Injury (2348)

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was not provided, a review of the device history records could not be performed.The device has not been returned to the manufacturer for evaluation, however image have been provided.The investigation of the reported event is currently underway.

Event Description

It was reported that during a fistula angioplasty procedure, the stent graft allegedly failed to expand after several attempts.There was no reported patient injury.

Manufacturer Narrative

Investigation summary: the physical sample was not returned.Images were provided demonstrating the placed covered stent in the vessel with reduced cross section at the distal end which led to confirmed result for construction of flow.In this case poor information was available in regards to the baseline procedure.Based on the information available the reported narrowing was confirmed.A definite root cause could not be determined.Labeling review: in reviewing the relevant labeling for this product the potential issue was found addressed.The ifu state: 'prior to covered stent implantation refer to the sizing table (table 1) and read the instructions for use.Careful attention should be paid to ensure the device is appropriately sized to the vessel diameter, taking into account any change in the vessel diameter that may have resulted from previous interventions.' in regards to pta the ifu state: 'pre-dilate the stenosis with a pta balloon catheter of appropriate length and diameter for the lesion to be treated.', and 'post dilation of the covered stent must be performed using an appropriately sized pta balloon catheter to avoid damage to the covered stent.' 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.

Event Description

It was reported approximately one month post stent placement procedure, the device allegedly found narrow.Reportedly, post dilatation was performed.The current patient status was unknown.

• Brand Name: COVERA VASCULAR COVERED STENT
• Type of Device: VASCULAR COVERED STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 10418779
• MDR Text Key: 203521812
• Report Number: 9681442-2020-00194
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• PMA/PMN Number: P170042
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK COVERA
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention