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

Catalog Number AASME08080

Device Problem Obstruction of Flow (2423)

Patient Problem Stenosis (2263)

Event Date 02/26/2021

Event Type  Injury  

Manufacturer Narrative

The catalog number identified has not been cleared in the us but is similar to the covera plus vascular covered stent that are cleared in the us.The pro code and 510 k number for the covera plus vascular covered stent are identified.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: 08/2021).Device not returned.

Event Description

It was reported that some time post stent graft placement procedure, the patient experienced re-stenosis.The current status of patient was unknown.

Event Description

It was reported that approximately nine months post stent graft placement in left external iliac artery via ipsilateral approach, the patient experienced re-stenosis.The current status of patient was unknown.

Manufacturer Narrative

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 that are cleared in the us.The pro code and 510 k number for the covera plus vascular covered stent are identified in d2 and g4.H10: manufacturing review: the lot history record of this lot was 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 for evaluation and image was not provided for review.Pre- and post-dilation were reported to be performed upon index procedure.Based on the investigation of the provided information, the investigation is 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 potential issue.Under 'potential complications may include.But are not limited to' the instructions for use state: '(¿) restenosis (¿) thrombus'.Regarding the preparation of the lesion, 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'.Moreover, the instructions for use states: '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'.Holding and handling of the system for regular stent deployment was found sufficiently described.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
• 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: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 12587524
• MDR Text Key: 275134153
• Report Number: 9681442-2021-00545
• Device Sequence Number: 1
• Product Code: PFV
• 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,Foreign,Study,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/13/2022

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: AASME08080
• Device Lot Number: ANDV1844
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/10/2021
• Initial Date FDA Received: 10/07/2021
• Supplement Dates Manufacturer Received: 01/19/2022
• Supplement Dates FDA Received: 01/19/2022
• 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: 56 YR
• Patient Sex: Male