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

Model Number	AVSM07040
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Aneurysm (1708); Thrombosis/Thrombus (4440); Restenosis (4576); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 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: 10/2021).
Event or Problem Description
It was reported through the results of a clinical trial, that approximately two days post index procedure, the subject developed 50 % of target lesion stenosis.Standard pta was used to successfully treat the target lesion.The current patient status was not provided.
Event or Problem Description
It was reported through the results of a clinical trial, that approximately two days post index procedure, the patient developed 50 % of target lesion stenosis.A standard pta was used to successfully treat the target lesion.The current patient status was not provided.
Additional 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.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 of the covera vascular covered stent sufficiently address the potential complications and adverse events.The 're-stenosis' is included as one of the potential complications, which could be associated with covered stent specific events such as 'misplacement, migration, embolism, fracture, compression, kinking and insufficient covered stent expansion'.Regarding the preparation of the device and 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 after stent deployment: ´'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.' h10: (expiry date: 10/2021).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.
Additional Manufacturer Narrative
H10: the file was reassessed for reportability and determined to be no longer reportable.Since an initial mdr was submitted, therefore, the file will remain assessed as a serious injury.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.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: the review of the instructions for use was not performed, since the reported re-intervention has been updated as being not related to the target lesion or the procedure.H10: d4 (expiry date: 10/2021).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 or Problem Description
It was reported through the results of a clinical trial, that approximately two days post index procedure, the subject developed non-target lesion stenosis.Standard pta was used to successfully treat the non-target lesion.The current patient status was not provided.
Additional Manufacturer Narrative
H10: additional information was received, and the file was reassessed for reportability and determined to be reportable as serious injury.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 as the stent remains implanted.Also, no x-ray images were provided for evaluation.Therefore, the reported restenosis could not be verified.No irregularities or complication occurred during initial stent placement; pre dilation of the lesion and post dilation of the stent was performed.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: relevant labeling applicable for this product was reviewed; it was found that the instruction for use sufficiently address the potential risk associated with the use of the covera vascular covered stent.Based on the instruction for use complications and adverse events may include the usual complications associated with endovascular stent and covered stent placement and dialysis shunt revisions, which includes obstruction of flow and restenosis of the target vessel.H10: d4 (expiry date: 10/2021), g3.H11: b3, b5, g1, 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.
Event or Problem Description
It was reported through the results of the clinical trial that approximately ten months and fifteen days post a covered stent placement, the subject developed hundred percent access thrombosis.It was further reported that approximately one year three months and thirteen days post index procedure, the subject developed with sixty percent of target lesion restenosis.Reportedly, a standard percutaneous transluminal angioplasty was used to successfully treat the target lesion and access thrombosis.The current status of the patient is unknown.

• Brand Name: COVERA VASCULAR COVERED STENT
• Common Device Name: 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: 12251208
• Report Number: 9681442-2021-00417
• Device Sequence Number: 17355529
• Product Code: PFV
• UDI-Device Identifier: 00801741106231
• UDI-Public: (01)00801741106231
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P170042
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Study,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/02/2024

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
• Operator of Device: Health Professional
• Device Model Number: AVSM07040
• Device Catalogue Number: AVSM07040
• Device Lot Number: ANDX4981
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/06/2021
• Supplement Date Received by Manufacturer: 11/12/2021; 12/02/2021; 03/29/2024
• Initial Report FDA Received Date: 07/30/2021
• Supplement Report FDA Received Date: 11/16/2021; 12/04/2021; 04/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ASPIRIN; ASPIRIN
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 92 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American