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

Model Number AVSM09060

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

Patient Problems Stenosis (2263); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/19/2019

Event Type  Injury  

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: 11/2017).

Event Description

It was reported through the results of a clinical trial, that the subject developed adverse event of pulsatility that was possibly related to the study device.The adverse event was recovered.Approximately two years six months post index procedure, the subject developed 50 % of target lesion stenosis.Standard percutaneous transluminal angioplasty (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, that the patient developed adverse event of pulsatility that was possibly related to the study device.The adverse event was recovered.Approximately two years six months post index procedure, the patient developed 50 % of target lesion stenosis.A standard percutaneous transluminal angioplasty (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.There were no reported issues with the delivery system; the stent was successfully placed.Pre- and post-dilation were reported to be performed upon index procedure.Based on the investigation of the provided information, the investigation is inconclusive for the reported issue.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 of the covera vascular covered stent sufficiently address the potential complications under 'potential complications may include.But are not limited to': '(¿)thrombotic occlusion, restenosis of the target lesion requiring reintervention (¿)'.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 vein'.Holding and handling of the system for regular stent deployment was found sufficiently described.H10: d4 (expiry date: 11/2017), 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.There were no reported issues with the delivery system; the stent was successfully placed.Pre- and post-dilation were reported to be performed upon index procedure.Based on the investigation of the provided information, the investigation is inconclusive for the reported issue.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 of the covera vascular covered stent sufficiently address the potential complications under 'potential complications may include.But are not limited to': '(¿)thrombotic occlusion, restenosis of the target lesion requiring reintervention (¿)'.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 vein'.Holding and handling of the system for regular stent deployment was found sufficiently described.H10: d4 (expiry date: 11/2017), g3.H11: b3.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 approximately two years six months post index procedure, the patient developed 50 % of target lesion stenosis.A standard percutaneous transluminal angioplasty (pta) was used to successfully treat the target lesion.The current patient status was not provided.

• 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: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 12472908
• MDR Text Key: 271447086
• Report Number: 9681442-2021-00511
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00801741106347
• UDI-Public: (01)00801741106347
• 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
• Report Date: 02/09/2022

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 Model Number: AVSM09060
• Device Catalogue Number: AVSM09060
• Device Lot Number: ANAY0946
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/19/2021
• Initial Date FDA Received: 09/15/2021
• Supplement Dates Manufacturer Received: 12/30/2021; 02/09/2022
• Supplement Dates FDA Received: 12/31/2021; 02/14/2022
• 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
• Treatment: ASPIRIN.; ASPIRIN.; ASPIRIN.; ASPIRIN
• Patient Outcome(s): Required Intervention
• Patient Age: 85 YR
• Patient Sex: Female
• Patient Weight: 53 KG
• Patient Ethnicity: Hispanic
• Patient Race: White