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

Model Number AVFM09040

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Ischemia (1942)

Event Date 02/01/2022

Event Type  Injury  

Manufacturer Narrative

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.The physical sample was not returned for evaluation.The stent remains implanted.No x-ray images were provided for evaluation.Therefore, the alleged restenosis can not be reproduced.Pre dilation as well as post dilation was performed, and the pta balloon was extended into healthy tissue; there was no report of any irregularities or complication during initial stent placement.Based on the information available an alleged device relation could not be verified.Based on the information available the investigation is closed with inconclusive result.A definitive root cause could not be determined based upon the available information.In reviewing the relevant labeling for this product, it was found that the instructions for use sufficiently address the potential risk.Based on the instructions for use complications and adverse events associated with the use of the covera plus vascular covered stent may include the usual complications associated with endovascular stent and covered stent placement and dialysis shunt revisions, which includes restenosis of the target vessel.Regarding pre and post dilation 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.Avoid balloon dilation in the healthy, non-stenosed segment of the vessel." holding and handling of the system for regular deployment was found sufficiently described.(expiry date: 04/2022).Device not returned.

Event Description

It was reported through the results of a clinical trial, that approximately six months and five days post stent placement procedure, the patient had an adverse event of steal syndrome.It was further reported that patient underwent surgical procedure for steal syndrome.The adverse event relationship to study device was possibly related, av access circuit was definitely related and not related to the procedure.The current status of the patient was not provided.

• 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: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 15665404
• MDR Text Key: 302340892
• Report Number: 9681442-2022-00312
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00801741106545
• UDI-Public: (01)00801741106545
• 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,Study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AVFM09040
• Device Catalogue Number: AVFM09040
• Device Lot Number: ANER5065
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/28/2022
• Initial Date FDA Received: 10/25/2022
• 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): Required Intervention
• Patient Sex: Female
• Patient Weight: 138 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White