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

Catalog Number AVSM10060

Device Problems Difficult to Remove (1528); Activation Failure (3270)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/19/2018

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a manufacturing review will 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.

Event Description

It was reported that during a stent graft deployment procedure for venous anastomosis of a graft with 10% stenosis, the covered stent allegedly partially deployed.It was further reported that there was difficult removing the delivery system.Another stent was used to open the closed segment of the partially deployed covered stent.There was no reported patient injury.

• Brand Name: COVERA VASCULAR COVERED STENT SYTEM
• 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 ; 1625 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 8103912
• MDR Text Key: 128391793
• Report Number: 9681442-2018-00205
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00801741106392
• UDI-Public: (01)00801741106392
• 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: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/26/2018

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
• Device Operator: Health Professional
• Device Catalogue Number: AVSM10060
• Device Lot Number: ANCT4161
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/30/2018
• Initial Date FDA Received: 11/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1