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

Catalog Number AASME10060

Device Problem Obstruction of Flow (2423)

Patient Problem Stenosis (2263)

Event Date 02/12/2020

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was provided, a manufacturing review will be 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.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.The catalog number identified has not been cleared in the u.S.But, it is similar to the covera plus vascular covered stent products that are cleared in the us.The 510 k number and pro code for the covera plus vascular covered stent products are identified.(expiry date: 12/2021).

Event Description

It was reported that approximately three months post stent graft implantation in the left common iliac artery, the vessel allegedly experienced restenosis.The patient is currently oligosymptomatic.

Event Description

It was reported that approximately three months post stent graft implantation in the left common iliac artery, the vessel allegedly experienced restenosis.The patient is currently oligosymptomatic.

Manufacturer Narrative

H10: the catalog number identified in section d4 has not been cleared in the u.S.But, it is similar to the covera plus vascular covered stent products that are cleared in the us.The 510 k number and pro code for the covera plus vascular covered stent products are identified in d2 and g5.Manufacturing review: 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 the specification prior to shipment.Investigation summary: the stent remains implanted.Therefore, no product is available for evaluation.Based on the report of the physician a duplex sonography was performed to diagnose a recurrent stenosis in the left arteria iliaca communis, the target vessel of the initial stent placement.There is no reference to an x-ray examination.Therefore no x-ray images are available to verify the integrity of the stent.Based on the information available the investigation is closed with inconclusive result.A definite root cause for the reported event could not be determined.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.H10: d4 (expiry date: 12/2021).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 PLUS 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: 9814917
• MDR Text Key: 187056147
• Report Number: 9681442-2020-00062
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00801741136023
• UDI-Public: (01)00801741136023
• Combination Product (y/n): N
• PMA/PMN Number: P170042
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AASME10060
• Device Lot Number: ANDV1995
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/13/2020
• Initial Date FDA Received: 03/10/2020
• Supplement Dates Manufacturer Received: 08/11/2020
• Supplement Dates FDA Received: 08/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: APIRIN; APIRIN; ATORVASTATIN; ATORVASTATIN; CLOPIDOGREL; CLOPIDOGREL; HEPARIN; HEPARIN
• Patient Outcome(s): Other
• Patient Age: 59 YR
• Patient Weight: 70