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

Model Number	AVSM10080
Medical Device Problem Codes	Obstruction of Flow (2423); Material Twisted/Bent (2981)
Health Effect - Clinical Code	Restenosis (4576)
Date of Event	04/25/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported through the results of a clinical trial, that approximately one month three days post index stent placement procedure, patient had an adverse event of collapsed stent and target lesion restenosis.It was further reported that standard pta was performed.Two days later the collapsed covered stent was surgically removed and another stent was placed; the procedure was successful.The current status of the patient is not provided.
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiry date: 10/2023).
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 explanted covered stent was returned for evaluation, and images were provided demonstrating the explanted stent on the table after the surgery, however, strut irregularity or covering issue potentially related to the alleged collapse could not be identified.Images demonstrating the collapsed stent inside the vessel / restenosis were not provided which leads to inconclusive evaluation result.Based on the investigation of the provided information, the investigation is inconclusive for reported issues.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.In regards to size selection the instructions for use state: 'straight device configurations are intended for use in anatomies where the diameter of the outflow vessel is equal to or smaller than the diameter of the inflow vessel.Flared device configurations are intended for use in anatomies where the diameter of the outflow vessel segment is larger than the inflow segment.', a 'covered stent diameter selection' table is part of the instructions for use describing the relationship between covered stent diameter and recommended oversizing; based on this table the oversizing was correct.In regards to pta the instructions for use state: 'post dilation of the covered stent must be performed using an appropriately sized pta balloon catheter to avoid damage to the covered stent.The covered stent cannot be post dilated beyond its labeled diameter.', and 'pre-dilate the stenosis with a pta balloon catheter of appropriate length and diameter for the lesion to be treated.' under covered stent specific events the instructions for use state: '(.), kinking and insufficient covered stent expansion.' holding and handling of system was found described, in particular the instructions for use state: 'do not touch the distal catheter assembly (i.E.The dark brown catheter segment) during covered stent deployment since this may interfere with covered stent deployment and may lead to misplacement'.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 : see h10.
Event or Problem Description
It was reported through the results of a clinical trial, that approximately one month three days post index stent placement procedure, patient had an adverse event of collapsed stent and target lesion restenosis.It was further reported that standard pta was performed.Two days later the collapsed covered stent was surgically removed and another stent was placed; the procedure was successful.

• 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: 14470675
• Report Number: 9681442-2022-00157
• Device Sequence Number: 4699959
• Product Code: PFV
• UDI-Device Identifier: 00801741106408
• UDI-Public: (01)00801741106408
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P170042
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2022

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: AVSM10080
• Device Catalogue Number: AVSM10080
• Device Lot Number: ANFX4111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/28/2022
• Supplement Date Received by Manufacturer: 06/20/2022
• Initial Report FDA Received Date: 05/23/2022
• Supplement Report FDA Received Date: 06/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 77 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White