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

Catalog Number AASME07080

Device Problems Obstruction of Flow (2423); Inaccurate Information (4051)

Patient Problem Stenosis (2263)

Event Date 02/24/2021

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history records 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 us but is similar to the covera plus vascular covered stent system products that are cleared in the us.The pro code and 510 k number for the covera plus vascular covered stent system products are identified.(expiry date: 03/2022).Device not returned.

Event Description

It was reported that post stent graft placement procedure, the labeling was allegedly unclear which leads to a stenosis without pulmonary vascular resistance (pvr) calculation.The patient status was unknown.

Manufacturer Narrative

H10: manufacturing review: a review of manufacturing records was not performed, as additional complaints have not been reported for this lot.Based on the information available it is not reasonably suggested that a manufacturing process may have caused or contributed to the reported issue.However, 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 sample was not returned to the manufacturer for evaluation, therefore the returned sample analysis could not be performed and image was not provided for evaluation.Based on the investigation of the provided information, the investigation is closed as inconclusive.A definite root cause for the reported event could not be determined.Labeling review: in reviewing the relevant labeling, it was found that the instructions for use sufficiently address the 'restenosis' as one of its potential complications.The covered stent specific events which may led to the clinical potential complications are stated in the instructions for use as: embolism; fracture; insufficient covered stent expansion; kinking; malposition; migration and misplacement; and side branch occlusion.H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the covera plus vascular covered stent system products that are cleared in the us.The pro code and 510 k number for the covera plus vascular covered stent system products are identified in d2 and g4.H10: d4 (expiry date: 03/2022), g3.H11: b5, h6 (method).H11: section a through f ¿ the information provide by bd represents all 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.H3 other text : device not returned.

Event Description

As part of a study, stenosis was identified by a core lab based on ultrasound images.The patient status was unknown.

• Brand Name: COVERA PLUS VASCULAR COVERED STENT
• Type of Device: VASCULAR COVERED STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstr. 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 12381194
• MDR Text Key: 268665496
• Report Number: 9681442-2021-00467
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00801741135880
• UDI-Public: (01)00801741135880
• 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: 10/19/2021

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: AASME07080
• Device Lot Number: ANEQ2693
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/02/2021
• Initial Date FDA Received: 08/28/2021
• Supplement Dates Manufacturer Received: 10/19/2021
• Supplement Dates FDA Received: 10/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR