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

Model Number AVSM08060

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

Patient Problems Numbness (2415); Thrombosis/Thrombus (4440); Restenosis (4576)

Event Date 10/12/2021

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was not provided, a review of the device history records could not 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.

Event Description

It was reported through the results of a clinical trial, approximately two months and nineteen days post index procedure, stenosis in target lesion was observed and standard pta was used to successfully treat the target lesion.The current patient status was not provided.

Manufacturer Narrative

H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: the sample was not returned for evaluation and x-ray images were not provided.Therefore, the investigation is inconclusive for the reported issue.A definitive root cause could not be determined based upon the available information.Labeling review: in reviewing the relevant labeling, it was found that the instructions for use of the covera vascular covered stent sufficiently address the potential complications and adverse events.Under potential complications the instructions for use state 'thrombotic occlusion, restenosis of the target lesion requiring reintervention, 'in regards to pta the instructions for use state: '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 vein'.Holding and handling of system was found described, in particular the instructions for use state: 'do not touch the distal catheter assembly (i.E.The dark brown catheter segment) during covered stent deployment since this may interfere with covered stent deployment and may lead to misplacement'.H11: d4 (medical device catalog number).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 the results of a clinical trial, approximately two months and nineteen days post index procedure, stenosis in target lesion was observed and a standard pta was used to successfully treat the target lesion.The current patient status was not provided.

Manufacturer Narrative

H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: the sample was not returned for evaluation and x-ray images were not provided.Therefore, the investigation is inconclusive for the reported issue.A definitive root cause could not be determined based upon the available information.Labeling review: in reviewing the relevant labeling, it was found that the instructions for use of the covera vascular covered stent sufficiently address the potential complications and adverse events.Under potential complications the instructions for use state '(¿) thrombotic occlusion, restenosis of the target lesion requiring reintervention, (¿)'.In regards to pta the instructions for use state: '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 vein'.Holding and handling of system was found described, in particular the instructions for use state: 'do not touch the distal catheter assembly (i.E.The dark brown catheter segment) during covered stent deployment since this may interfere with covered stent deployment and may lead to misplacement'.H10: g3.H11: h6(method).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.

Event Description

It was reported through the results of a clinical trial, approximately two months and nineteen days post index procedure, stenosis in target lesion was observed and standard pta was used to successfully treat the target lesion.The current patient status was not provided.

Manufacturer Narrative

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 sample was not returned for evaluation and x-ray images were not provided.Therefore, the investigation is inconclusive for the reported issue.A definitive root cause could not be determined based upon the available information.Labeling review: in reviewing the relevant labeling, it was found that the instructions for use of the covera vascular covered stent sufficiently address the potential complications and adverse events.Under potential complications the instructions for use state '(¿) thrombotic occlusion, restenosis of the target lesion requiring reintervention, (¿)'.In regards to pta the instructions for use state: '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 vein'.Holding and handling of system was found described, in particular the instructions for use state: 'do not touch the distal catheter assembly (i.E.The dark brown catheter segment) during covered stent deployment since this may interfere with covered stent deployment and may lead to misplacement'.H10: b5, g3.H11: g1, d4(medical device lot number).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 the results of a clinical trial, approximately two months and nineteen days post index procedure, approximately six months and twelve days post index procedure, stenosis in target lesion was observed and standard pta was used to successfully treat the target lesion.The current patient status was not provided.

Event Description

It was reported through the results of a clinical trial, approximately two months and nineteen days post index procedure, approximately six months and twelve days post index procedure and approximately ten months and two days post index procedure, stenosis in target lesion was observed, and standard pta was used to successfully treat the target lesion.It was further reported that approximately eleven months and thirteen days post index procedure, thrombosis was diagnosed.Standard percutaneous transluminal angioplasty (pta) and thrombectomy/thrombolysis were used to successfully treat the target lesion.The current patient status was not provided.

Manufacturer Narrative

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 sample was not returned for evaluation and x-ray images were not provided.Therefore, the investigation is inconclusive for the reported issue.A definitive root cause could not be determined based upon the available information.Labeling review: in reviewing the relevant labeling, it was found that the instructions for use (ifu) sufficiently address the potential complications and adverse events.Under potential complications theinstructions for use state '(¿) thrombotic occlusion, restenosis of the target lesion requiring reintervention, (¿)'.In regards to pta the instructions for use state: '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 vein'.Holding and handling of system was found described, in particular the instructions for use state: 'do not touch the distal catheter assembly (i.E.The dark brown catheter segment) during covered stent deployment since this may interfere with covered stent deployment and may lead to misplacement'.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.

Event Description

It was reported through the results of a clinical trial that two months and twenty-one days post an index procedure of stent graft placement in the cephalic vein arch, stenosis in the target lesion was observed, and standard pta was used to successfully treat the target lesion.It was further reported that eleven months and fourteen days post the index procedure, the subject experienced access thrombosis in the cephalic vein outflow and also experienced restenosis in the cephalic vein arch.Reportedly, standard percutaneous transluminal angioplasty and thrombolysis with tissue plasminogen activator (tpa) were performed and a covered stent was successfully placed in the outflow vein for treatment, and the reintervention was successful.The current patient status was not provided.

Manufacturer Narrative

H10: manufacturing review: 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 for evaluation and no images were provided for review which leads to inconclusive evaluation result.There were no reported issues with the delivery system; the stent was successfully placed.Pre- and post-dilation were performed upon index procedure.Therefore, 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 potential complications and adverse events.Under potential complications the instructions for use state '(¿) thrombotic occlusion, restenosis of the target lesion requiring reintervention, (¿)'.In regards to pta the instructions for use state: '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 vein'.Holding and handling of system was found described, in particular the instructions for use state: 'do not touch the distal catheter assembly (i.E.The dark brown catheter segment) during covered stent deployment since this may interfere with covered stent deployment and may lead to misplacement'.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.

• Brand Name: COVERA 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: 12809835
• MDR Text Key: 280752963
• Report Number: 9681442-2021-00593
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00801741106293
• UDI-Public: (01)00801741106293
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup,Followup,Followup
• Report Date: 04/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AVSM08060
• Device Catalogue Number: AVSM08060
• Device Lot Number: ANFP2297
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/24/2024
• 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; Other
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 69 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White