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

Catalog Number AASME08060

Device Problem Obstruction of Flow (2423)

Patient Problems Pain (1994); Obstruction/Occlusion (2422)

Event Date 12/08/2020

Event Type  Injury  

Manufacturer Narrative

The catalog number identified has not been cleared in the us but is similar to the covera vascular covered stent products that are cleared in the us.The pro code and 510k number for the covera vascular covered stent products is identified.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.Medical device expiry date: 08/2021.

Event Description

It was reported that approximately eight months post stent placement, the stent allegedly had an occlusion in the left artria iliaca externa which was confirmed by an ultrasound examination.The patient experienced sudden pain and unable to walk much distance.The patient's current status 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 vascular covered stent products that are cleared in the us.The pro code and 510k number for the covera vascular covered stent products is 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.Investigation summary: the stent remains implanted.No x-ray images were provided for evaluation.Restenosis of a covered stent may be caused by various factors and may even occur inside non-defective stents that have been correctly placed.Restenosis may be related to the general condition of the patient, to the vascular conditions of the patient, or to medication.Irregular placement or insufficient pre- and/or post dilatation may be contributing factors.In this case pre dilation as well as post dilation was performed; there was no report of any irregularities or complication during initial stent placement.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: in reviewing the relevant labeling for this product, it was found that the instructions for use sufficiently address the potential risk.Based on the instructions for use complications and adverse events associated with the use of the covera plus vascular covered stent may include the usual complications associated with endovascular stent and covered stent placement and dialysis shunt revisions, which includes restenosis of the target vessel.Regarding pre and post dilation 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." h10: d4 (expiry date: 08/2021), g3.H11: 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.

Event Description

It was reported that approximately eight months post stent placement, the stent allegedly had an occlusion in the left artria iliaca externa which was confirmed by an ultrasound examination.The patient experienced sudden pain and unable to walk much distance.The patient's current status 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 vascular covered stent products that are cleared in the us.The pro code and 510k number for the covera vascular covered stent products is 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.Investigation summary: the stent remains implanted.No x-ray images were provided for evaluation.Restenosis of a covered stent may be caused by various factors and may even occur inside non-defective stents that have been correctly placed.Restenosis may be related to the general condition of the patient, to the vascular conditions of the patient, or to medication.Irregular placement or insufficient pre- and/or post dilatation may be contributing factors.In this case pre dilation as well as post dilation was performed; there was no report of any irregularities or complication during initial stent placement.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: in reviewing the relevant labeling for this product, it was found that the instructions for use sufficiently address the potential risk.Based on the instructions for use complications and adverse events associated with the use of the covera plus vascular covered stent may include the usual complications associated with endovascular stent and covered stent placement and dialysis shunt revisions, which includes restenosis of the target vessel.Regarding pre and post dilation 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." h10: d4 (expiry date: 08/2021), g3, h6 (patient).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.

Event Description

It was reported that approximately eight months post stent placement, the stent allegedly had an occlusion in the left artria iliaca externa which was confirmed by an ultrasound examination.The patient experienced sudden pain and unable to walk much distance.The patient's current 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: 11123119
• MDR Text Key: 225265414
• Report Number: 9681442-2020-20146
• Device Sequence Number: 1
• Product Code: PFV
• 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,Followup
• Report Date: 07/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AASME08060
• Device Lot Number: ANDV1843
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention