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

Model Number	AVSM08080
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Restenosis (4576)
Date of Event	06/02/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history record is currently being 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.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 or Problem Description
It was reported through a clinical study that approximately, eight months and ten days, post stent placement procedure, the patient developed 70 % of target lesion stenosis.Standard pta was used for treatment.The re-intervention procedure was successful, and no new access was created.The current status of the patient is unknown.
Event or Problem Description
It was reported through a clinical study that approximately, eight months and ten days, post stent placement procedure, the patient developed 70 % of target lesion stenosis.Standard pta was used for treatment.The re-intervention procedure was successful, and no new access was created.The current status of the patient is unknown.
Additional 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.Based on the information available it is not reasonably suggested that a manufacturing process may have caused or contributed to the reported issue.Investigation summary: the physical device was not returned and no x-ray images were provided for evaluation.Based on the investigation of the provided information, the investigation is closed as inconclusive.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 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: 12/2022).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.

• 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: 15196769
• Report Number: 9681442-2022-00235
• Device Sequence Number: 6414023
• Product Code: PFV
• UDI-Device Identifier: 00801741106309
• UDI-Public: (01)00801741106309
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2022

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
• Operator of Device: Health Professional
• Device Model Number: AVSM08080
• Device Catalogue Number: AVSM08080
• Device Lot Number: ANEZ3341
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/20/2022
• Supplement Date Received by Manufacturer: 09/23/2022
• Initial Report FDA Received Date: 08/10/2022
• Supplement Report FDA Received Date: 09/27/2022
• 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 Sex: Female
• Patient Weight: 85 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White