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

Model Number	AVFM10100
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Device Overstimulation of Tissue (1991); Restenosis (4576)
Date of Event	09/17/2020
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 (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 expiration date: 01/2022.
Event or Problem Description
It was reported through the results of a clinical trial, that during post-dilation of the vascular covered stent, spasm of the outflow vein occurred and was resolved with pta.The event was considered resolved and the patient was discharged the same day.The current patient status was not provided.
Event or Problem Description
It was reported through the results of a clinical trial, that during post-dilation of the vascular covered stent, spasm of the outflow vein occurred and was resolved with pta.The event was considered resolved and the patient was discharged the same day.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, previously.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: neither sample nor images were provided for evaluation.The issue could not be re produced which led to inconclusive evaluation result.Potential factors that could have led or contributed to the reported event have been evaluated.Therefore, previous investigations of similar complaints have been reviewed.Spasm of vein after covered stent placement procedure may be caused by various factors and may even occur inside non-defective covered stents that have been correctly placed.Vessel spasm may be related to patient condition or procedural steps, e.G.Pre or post dilation.Vessel stress during regular deployment, insertion or withdrawal may be further factors.In this case, the product was used without introducer.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 the potential issue was found addressed.The instructions for use closely describes holding and handling of the device throughout the procedure including accessories to be used.The instructions for use states under materials required: 'introducer sheath with appropriate inner diameter'.Furtherly, 'venous spasm' was found mentioned as potential complication that may occur.The instructions for use further state: 'avoid balloon dilation in the healthy, non-stenosed segment of the vein.' 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.H3 other text : device not returned.
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.The issue could not be re produced which led to inconclusive evaluation result.The product was used without introducer.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 the potential issue was found addressed.The instructions for use closely describes holding and handling of the device throughout the procedure including accessories to be used.The instructions for use states under materials required: 'introducer sheath with appropriate inner diameter'.Furtherly, 'venous spasm' was found mentioned as potential complication that may occur.The instructions for use further state: 'avoid balloon dilation in the healthy, non-stenosed segment of the vein.' h10: d4 (expiry date: 01/2022), 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.H3 other text : device not returned.
Event or Problem Description
It was reported through results of a clinical trial that some time post index procedure, the subject had adverse event spasm of outflow vein.It was further reported that, one year and one month post index procedure, core lab result analysis identified the target lesion had initial stenosis of forty-one percent.Treatment re-intervention was successful, and the patient recovered with ten percent residual stenosis.However, 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: 10691973
• Report Number: 9681442-2020-20004
• Device Sequence Number: 11501438
• Product Code: PFV
• UDI-Device Identifier: 00801741106613
• UDI-Public: (01)00801741106613
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: P170042
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Other,Study,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/27/2023

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: AVFM10100
• Device Catalogue Number: AVFM10100
• Device Lot Number: ANEN4828
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/21/2020
• Supplement Date Received by Manufacturer: 05/11/2021; 02/08/2023
• Initial Report FDA Received Date: 10/16/2020
• Supplement Report FDA Received Date: 05/19/2021; 03/03/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 93 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White