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

Model Number AVSM09080

Device Problems Migration or Expulsion of Device (1395); Obstruction of Flow (2423); Material Twisted/Bent (2981); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Aneurysm (1708); Unspecified Tissue Injury (4559); Restenosis (4576)

Event Date 09/02/2021

Event Type  Injury  

Event Description

It was reported through the results of a clinical trial, that approximately forty five days post index procedure, the patient developed seventy percentage of target lesion stenosis.A standard pta was used to successfully treat the target lesion.The current patient status was not provided.

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.(expiry date: 03/2023).

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 for evaluation and image was not provided for review.Therefore, the investigation is inconclusive for the reported issue.There were no reported issues with the delivery system; the stent was successfully placed.Pre- and post-dilation were performed upon index procedure.The definitive root cause could not be determined based upon 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 'new lesions in the access circuit requiring reintervention, thrombotic occlusion, restenosis of the target lesion requiring reintervention, and 'misplacement, migration insufficient covered stent expansion.' 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'.A covered stent diameter selection table is part of the instructions for use describing the relationship between covered stent diameter and reference vessel diameter.H10: d4 (expiry date: 03/2023).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, that approximately forty five days post index procedure, the patient had an adverse event of material twist, migration and target lesion restenosis.A standard percutaneous transluminal angioplasty was used to successfully treat the target lesion.The current patient status is not provided.

Event Description

It was reported through the results of a clinical trial, that approximately forty five days post index procedure, the patient developed seventy percentage of target lesion stenosis.A standard pta was used to successfully treat the target lesion.The current patient status was not provided.

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 for evaluation and image was not provided for review.Therefore, the investigation is inconclusive for the reported issue.There were no reported issues with the delivery system; the stent was successfully placed.Pre- and post-dilation were performed upon index procedure.The definitive root cause could not be determined based upon 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: d4 (expiry date: 03/2023), 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.H3 other text : device not returned.

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 for evaluation and image was not provided for review.Therefore, the investigation is inconclusive for the reported issue.There were no reported issues with the delivery system; the stent was successfully placed.Pre- and post-dilation were performed upon index procedure.The definitive root cause could not be determined based upon 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, d4 (expiry date: 03/2023), g3.H11: h6 (device).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, that approximately forty five days post index procedure, the patient had an adverse event of material twist, migration and seventy percentage of target lesion stenosis.A 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 of post stent placement procedure, the patient had an adverse event of aneurysm, material twist, migration and target lesion restenosis.It was further reported that standard percutaneous transluminal angioplasty procedure and aneurysm repair was performed to treat the restenosis and aneurysm.The current patient status is not provided.

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 for evaluation and image was not provided for review.Therefore, the investigation is inconclusive for the reported issue.There were no reported issues with the delivery system; the stent was successfully placed.Pre- and post-dilation were performed upon index procedure.The definitive root cause could not be determined based upon 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 'new lesions in the access circuit requiring reintervention, thrombotic occlusion, restenosis of the target lesion requiring reintervention, pseudoaneurysm, (¿)', and 'misplacement, migration (.) insufficient covered stent expansion.' 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'.A covered stent diameter selection table is part of the instructions for use describing the relationship between covered stent diameter and reference vessel diameter.H10: b2, d4 (expiry date: 03/2023), g3, h6 (patient) 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: 12769791
• MDR Text Key: 280586638
• Report Number: 9681442-2021-00577
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00801741106354
• UDI-Public: (01)00801741106354
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AVSM09080
• Device Catalogue Number: AVSM09080
• Device Lot Number: ANFQ4516
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/31/2022
• 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): Other; Required Intervention
• Patient Age: 45 YR
• Patient Sex: Male
• Patient Weight: 86 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American