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

Model Number	AVSM09060
Medical Device Problem Codes	Positioning Failure (1158); Misfire (2532)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was not provided, a review of the device history record could not be performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.
Event or Problem Description
It was reported that during a vascular stent graft procedure through hepatic shunt, the device allegedly failed to deploy.The procedure was completed using another device.There was no reported patient injury.
Event or Problem Description
It was reported that during a vascular stent graft procedure, the device allegedly failed to deploy in a portal hepatic shunt.The procedure was completed using another device.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a device history record review could not be performed as the lot number is unknown.Investigation summary: the sample was returned for evaluation.Based on the investigation of the delivery system returned partial stent deployment as well the impossibility to deploy the stent completely is confirmed.A force transmitting component, the distal catheter segment inside the grip, was found broken.In this case the vessel was reported being tortuous; the intended placement site was a portal hepatic shunt which represents an off label use.Therefore the investigation is confirmed for the reported issue.Based on the information available a definite root cause for the reported event could not be determined.Labeling review: in reviewing the relevant instruction for use for this product, the potential issue was found addressed.Based on the instruction for use inaccurate deployment, failure to deploy, high deployment forces are delivery system specific events that could be associated with clinical complications.Covered stent deployment procedure was found sufficiently described.E.G., the instruction for use states: "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." regarding accessories the instruction for use states that heparinized saline, 0.035 inch guidewire, introducer sheath with appropriate inner diameter and balloon angioplasty catheter for pre and/or post dilation are required materials.Based on the instruction for use the covera¿ vascular covered stent is indicated for use in hemodialysis patients for the treatment of stenoses in the venous outflow of an arterio-venous (av) fistula and at the venous anastomosis of an eptfe or other synthetic av graft.The intended use in a portal hepatic shunt represents an off label use of the device.H10: g3.H11: h6 (results, conclusion).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 SYSTEM
• Common Device Name: VASCULAR COVERED STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstr. 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 10821929
• Report Number: 9681442-2020-20031
• Device Sequence Number: 2954414
• Product Code: PFV
• UDI-Device Identifier: 00801741106347
• UDI-Public: (01)00801741106347
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: P170042
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2021

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: AVSM09060
• Device Catalogue Number: AVSM09060
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2020
• Initial Date Received by Manufacturer: 10/15/2020
• Supplement Date Received by Manufacturer: 03/29/2021
• Initial Report FDA Received Date: 11/11/2020
• Supplement Report FDA Received Date: 03/31/2021
• 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
• Patient Age: 74 YR
• Patient Weight: 105