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

Model Number AVSM10100

Device Problems Break (1069); Positioning Failure (1158)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The lot number was provided, a lot history review was performed.The device was returned to the manufacturer for evaluation.The investigation is confirmed for outer sheath fracture which made a successful deployment impossible.The definite root cause could not be determined based on the available information.The device is labeled for single use.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model avsm10100 covera vascular covered stent system allegedly experienced broken sheath and failed to deploy.This information was received from one source.One patient was involved with no reported patient injury.The male patient is (b)(6) years old and weighs (b)(6) lbs.

• Brand Name: COVERA VASCULAR COVERED STENT SYSTEM
• 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: 10271736
• MDR Text Key: 199892013
• Report Number: 9681442-2020-00154
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00801741106415
• UDI-Public: (01)00801741106415
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: AVSM10100
• Device Catalogue Number: AVSM10100
• Device Lot Number: ANDW3051
• Date Manufacturer Received: 06/30/2020
• Type of Device Usage: N
• Patient Sequence Number: 1