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

Model Number	AVSM09040
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Restenosis (4576)
Date of Event	04/21/2021
Type of Reportable Event	Serious Injury
Additional 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: 08/2022).Device not returned.
Event or Problem Description
It was reported through the results of a clinical trial, that approximately three months and three days post index procedure, the subject developed 50 % of target lesion stenosis.Standard pta and bare metal stent were used to successfully treat the target lesion.The current patient status was not provided.
Additional Manufacturer Narrative
H10: manufacturing review: the lot history record of this lot was 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 returned sample analysis could not be performed as the physical device could not be possibly returned and no x-ray images were provided for evaluation.Therefore the reported adverse event could not be confirmed.A definite root cause 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: d4 (expiry date: 08/2022), g3.H11: h6 (patient, method).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.
Event or Problem Description
It was reported through the results of a clinical trial, that approximately three months and three days post index procedure, the subject developed 50 % of target lesion stenosis.Standard pta and bare metal stent were used to successfully treat the target lesion.The current patient status was not provided.

• 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: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 11883175
• Report Number: 9681442-2021-00342
• Device Sequence Number: 13780591
• Product Code: PFV
• UDI-Device Identifier: 00801741106330
• UDI-Public: (01)00801741106330
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Report Date (Section B): 11/08/2021

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: AVSM09040
• Device Catalogue Number: AVSM09040
• Device Lot Number: ANEV3047
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/30/2021
• Supplement Date Received by Manufacturer: 11/08/2021
• Initial Report FDA Received Date: 05/26/2021
• Supplement Report FDA Received Date: 11/10/2021
• 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 AND APIXABAN.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 93 KG
• Patient Ethnicity: Hispanic
• Patient Race: White