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

Catalog Number UNK COVERA

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problems Aneurysm (1708); Injury (2348)

Event Date 02/05/2019

Event Type  Injury  

Manufacturer Narrative

The catalog number identified has not been cleared in the us but is similar to the covera stent graft products that are cleared in the us.The 510 k number and pro code for the covera stent graft products are identified.As the lot number for the device was not provided, a manufacturing review 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 (ifu) 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.Journal article citation: caradu, c., dubourg, a.P., colacchio, e.C., midy, d., bérard, x., & ducasse, e.(2019).Endovascular treatment of complex aneurysms with the use of covera stent grafts.Journal of vascular and interventional radiology, 30(12).Doi: 10.1016/j.Jvir.2019.05.004.

Event Description

It was reported in an article from the journal of vascular and interventional radiology (jvir) titled " endovascular treatment of complex aneurysms with the use of covera stent grafts " that after the stent graft placement, immediate postoperative aphasia identified in one patient with complete recovery and it was associated with the use of bilateral brachial approach for the implantation of 3 chimneys and the navigation through the aortic arch by larger catheter sheath.In one patient, persistent type ia "short" gutter endoleak remained under surveillance with the stability of the sac at 49 mm at 2 months follow up.

• 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
• Manufacturer (Section G): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• Manufacturer Contact: judith ludwig ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 9720594
• MDR Text Key: 182331261
• Report Number: 9681442-2020-00049
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P170042
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2020
• 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: 01/22/2020
• 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): Other