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

Model Number AVSM07080

Device Problem Malposition of Device (2616)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

This report summarizes one malfunction.A review of the malfunction indicated that model avsm07080 vascular covered stent was allegedly experienced malposition of device.This report was received from one source.The event involved a patient with no known impact to the patient.The (b)(6) male patient was (b)(6).

Manufacturer Narrative

H10: as the lot number for the device was provided, a lot history review was performed.The physical sample was not returned and not available for evaluation.The investigation was inconclusive because no device sample and no x-ray images were provided.A definite root cause has not been determined.The device was labeled for single use.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.

Event Description

This report summarizes one malfunction.A review of the malfunction indicated that model avsm07080 vascular covered stent allegedly experienced malposition of device.This report was received from one source.The event involved a patient with no known impact to the patient.The 69 year old male patient weighed 73 kg.

• 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: 10271441
• MDR Text Key: 199700120
• Report Number: 9681442-2020-00151
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00801741106255
• UDI-Public: (01)00801741106255
• 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: 10/08/2020

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: No Information
• Device Model Number: AVSM07080
• Device Catalogue Number: AVSM07080
• Device Lot Number: ANDX1973
• Initial Date Manufacturer Received: 06/30/2020
• Initial Date FDA Received: 07/14/2020
• Supplement Dates Manufacturer Received: 09/30/2020
• Supplement Dates FDA Received: 10/08/2020
• Patient Sequence Number: 1