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

Model Number AVSM08060

Device Problem Malposition of Device (2616)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The lot number was provided and a lot history review was performed.The return of the sample is pending.The company is still investigating the issue at this time.

Event Description

The report summarizes one malfunction.A review of the reported information indicates that model avsm08060, vascular covered stent, allegedly experienced malposition of the device.This information was "recieved" from a single source.This malfunction involved a patient with no consequences.The patient's age, weight, and gender were not provided.

Event Description

The report summarizes one malfunction.A review of the reported information indicates that model avsm08060, vascular covered stent, allegedly experienced malposition of the device.This information was received from a single source.This malfunction involved a patient with no consequences.The patient's age, weight, and gender were not provided.

Manufacturer Narrative

H10: the lot no for the device was provided, therefore a lot history review was 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 h11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

• 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
• MDR Report Key: 9941539
• MDR Text Key: 187390902
• Report Number: 9681442-2020-00090
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00801741106293
• UDI-Public: (01)00801741106293
• 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: 06/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: AVSM08060
• Device Catalogue Number: AVSM08060
• Device Lot Number: ANDW3503
• Date Manufacturer Received: 06/19/2020
• Patient Sequence Number: 1