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

Model Number	AVSM10080
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was not provided, a review of the device history records could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.
Event or Problem Description
It was reported that during the stent graft placement, he device allegedly had malposition issues.There was no reported patient injury.
Event or Problem Description
It was reported that during the stent graft placement, he device allegedly had malposition issues.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a lot history review, a device history record review and complete manufacturing review could not be conducted for the investigation as the lot number is unknown.Investigation summary: the sample was not returned for evaluation and image was not provided.Therefore, the investigation is inconclusive for the reported issue.A definitive root cause could not be determined based upon the available information.Labeling review: in reviewing the relevant labeling for this product the potential issue was found addressed.The instruction for use describe holding and handling of the system throughout the procedure; in particular the instruction for use state: '(¿) maintain a stationary hold on the white stability sheath during covered stent deployment (¿).Hold the white stability sheath as close as possible to the introducer without touching the dark brown moving catheter (¿).' a covered stent diameter selection table is part of the instruction for use describing the oversizing of the covered stent in regards to the vessel or graft diameter; the instruction for use state: '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.' h10: g3 h11: h6 (method) h11: section a through f ¿ the information provide 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 : device not returned.

• 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: 12164764
• Report Number: 9681442-2021-00398
• Device Sequence Number: 11931961
• Product Code: PFV
• UDI-Device Identifier: 00801741106408
• UDI-Public: (01)00801741106408
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 10/29/2021

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: AVSM10080
• Device Catalogue Number: AVSM10080
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/18/2021
• Supplement Date Received by Manufacturer: 10/29/2021
• Initial Report FDA Received Date: 07/14/2021
• Supplement Report FDA Received Date: 11/01/2021
• 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