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

Model Number	AVSM10100
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Activation Failure (3270)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 all specifications prior to shipment.Based on the investigation of the returned catheter sample neither a difficult deployment nor an expansion failure could be confirmed.The catheter sample was returned in released but good condition so that an indication for an expansion issue or difficult deployment could not be identified.Images documenting difficult deployment or expansion issue during deployment have not been provided.The alleged issue could not be re-produced which led to an inconclusive evaluation result.A definite root cause for the reported event could not be determined.The device is labeled for single use.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model avsm10100 vascular covered stent allegedly was difficult to deploy and failed to expand.A balloon was used to post dilate and another stent graft was deployed to cover the lesion.There was no reported patient injury.This information was received from one source.

• Brand Name: COVERA VASCULAR COVERED STENT SYSTEM
• Common Device Name: VASCULAR COVERED STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 8812545
• Report Number: 9681442-2019-00132
• Device Sequence Number: 19461410
• Product Code: PFV
• UDI-Device Identifier: 00801741106415
• UDI-Public: (01)00801741106415
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/22/2019

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: No Information
• Device Model Number: AVSM10100
• Device Catalogue Number: AVSM10100
• Device Lot Number: ANCZ1828
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2019
• Initial Report FDA Received Date: 07/22/2019
• Patient Sequence Number: 1