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

Model Number AVFM09060

Device Problems Difficult or Delayed Positioning (1157); Entrapment of Device (1212); Difficult to Remove (1528); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned for evaluation; therefore, the investigation is inconclusive for difficulty to deploy, difficulty to remove, entrapment, and material deformation as no objective evidence has been provided to confirm any alleged deficiency with the device.Based upon the available information, the definitive root cause is unknown.The device is labeled for single use.(b)(4).

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model avfm09060 vascular covered stent system allegedly experienced difficulty to deploy, difficulty to remove, entrapment, and material deformation.This information was received from a single source.The malfunction involved a patient with no reported consequence.The patient was reported as a female who weighed (b)(6) lbs.The patient¿s age was not reported.

Manufacturer Narrative

After further review of the details provided by the complainant, it was identified that the fda rn number was incorrect and the correct fda rn number is (b)(4).This number will not be changed on the emdr so that this report will remain connected and identify that the event was reported to the fda in a timely manner.The device has not been returned for evaluation; therefore, the investigation is inconclusive for difficulty to deploy, difficulty to remove, entrapment, and material deformation as no objective evidence has been provided to confirm any alleged deficiency with the device.Based upon the available information, the definitive root cause is unknown.The device is labeled for single use.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model avfm09060 vascular covered stent system allegedly experienced difficulty to deploy, difficulty to remove, entrapment, and material deformation.This information was received from a single source.The malfunction involved a patient with no reported consequence.The patient was reported as a female who weighed 115 lbs.The patient¿s age was not reported.

• Brand Name: COVERA VASCULAR COVERED STENT SYSTEM
• Type of Device: VASCULAR COVERED STENT SYSTEM
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 8783336
• MDR Text Key: 150849195
• Report Number: 2020394-2019-01479
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00801741106552
• UDI-Public: (01)00801741106552
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 10/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: AVFM09060
• Device Catalogue Number: AVFM09060
• Device Lot Number: ANCW0299
• Date Manufacturer Received: 09/30/2019
• Patient Sequence Number: 1