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

Model Number	AVFM10060
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2020
Type of Reportable Event	Malfunction
Additional 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, an image is provided for review.The investigation of the reported event is currently underway.(expiry date: 04/2022).
Event or Problem Description
It was reported that during a stent placement procedure, the device allegedly had a stent foreshortened.It was further reported that the another stent deployed to fill the gap.There was no reported patient injury.
Additional 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 physical sample was not available for evaluation; images provided demonstrate covered stent placement in the vessel including previously placed stent grafts, as reported.However, the images were taken with contrasted blood, and the resolution is poor so that a detailed strut structure analysis was impossible; a length measurement was not possible because of missing adequate scaling information.Images of the vessel without the covered stent were not provided so that a comparison to the condition before placement was not possible.The alleged issue cannot be reproduced which leads to inconclusive evaluation result.In this case the vessel was pre dilated but the system was used without an introducer sheath; the covered stent was placed to bridge two stent grafts which was considered a significant factor because entrapment may lead to misplacement.A definite root cause for the reported event could not be determined.Labeling review: in reviewing the relevant labeling for this product, the potential issue was found addressed.Holding and handling of the system throughout the procedure was found described, in particular the instructions for use state: 'do not touch the distal catheter assembly (i.E., the dark brown catheter segment) during covered stent deployment since this may interfere with covered stent deployment and may lead to misplacement', and 'for accurate placement, subtle repositioning may be performed during initial wheel activation while the covered stent is still compressed in the catheter.After deployment of approximately 15 mm, wait several seconds to allow the distal end of the covered stent to fully expand.Ensure the covered stent has wall apposition before completing deployment.' regarding resistance the instructions for use state: 'if unusual resistance is met during covered stent system introduction, the system should be removed and another covered stent system should be used.' under materials required the instructions for use state 'introducer sheath with appropriate inner diameter'.The instructions for use further state: 'the device has not been tested for use in an overlapped condition with a bare metal stent or 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 or Problem Description
It was reported that during a covered stent placement procedure in a pre-dilated vessel to bridge two stent grafts, the covered stent compressed.It was further reported that the physician deployed another covered stent to fill the gap.There was no reported patient injury.

• Brand Name: COVERA VASCULAR COVERED STENT
• Common Device Name: VASCULAR COVERED STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstr. 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 10815740
• Report Number: 9681442-2020-20029
• Device Sequence Number: 13928642
• Product Code: PFV
• UDI-Device Identifier: 00801741106590
• UDI-Public: (01)00801741106590
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: P170042
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2021

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
• Operator of Device: Health Professional
• Device Model Number: AVFM10060
• Device Catalogue Number: AVFM10060
• Device Lot Number: ANER5073
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/15/2020
• Supplement Date Received by Manufacturer: 06/16/2021
• Initial Report FDA Received Date: 11/10/2020
• Supplement Report FDA Received Date: 06/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other