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

Catalog Number AASME08040

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Restenosis (4576)

Event Date 06/22/2022

Event Type  Injury  

Event Description

It was reported through a clinical trial, that approximately one year and eleven months post stent placement procedure in the right a.Iliaca communis via ipsilateral approach, patient was diagnosed with in-stent re-stenosis.The current status of the patient is unknown.

Manufacturer Narrative

The catalog number identified has not been cleared in the us but is similar to the covera vascular covered stent that are cleared in the us.The pro code and 510 k number for the covera vascular covered stent are identified in common device name and pma/510k.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.Expiry date: 12/2021.

Manufacturer Narrative

H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the covera vascular covered stent that are cleared in the us.The pro code and 510 k number for the covera vascular covered stent are identified in d2 and g4.H10: 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.Based on the information available it is not reasonably suggested that a manufacturing process may have caused or contributed to the reported issue.Investigation summary: the sample was not returned for evaluation and no images were provided.There was no complication during index procedure.Pre- and post-dilation were performed upon index procedure.Based on the information available, the investigation is closed with inconclusive result.A definitive root cause could not be determined based upon the available information.Labeling review: review of the relevant labeling was conducted.Potential risks and contributing factors were found addressed.Restenosis was found to be referenced as a complication during use of the product.Regarding the placement the instructions for use states: "pre-dilate the stenosis with a pta balloon catheter of appropriate length and diameter for the lesion to be treated." and "post dilate the covered stent with an angioplasty balloon sized appropriately as to ensure complete wall apposition to the reference vessel.Avoid balloon dilation in the healthy, non-stenosed segment of the vessel." in addition, correct handling of system during deployment is described.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.H3 other text : device not returned.

Event Description

It was reported through a clinical trial, that one year, eleven months and fifteen days post stent placement procedure in the right a.Iliaca communis via ipsilateral approach, patient was diagnosed with in-stent re-stenosis.The current status of the patient is 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
• Manufacturer (Section G): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstr. 6; karlsruhe 76227 ; GM 76227
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 15787645
• MDR Text Key: 303552792
• Report Number: 9681442-2022-00329
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00801741135910
• UDI-Public: (01)00801741135910
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P170042
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/21/2022

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: AASME08040
• Device Lot Number: ANDZ3805
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/18/2022
• Initial Date FDA Received: 11/14/2022
• Supplement Dates Manufacturer Received: 11/21/2022
• Supplement Dates FDA Received: 12/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR
• Patient Sex: Female