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

Catalog Number	AVSM08060
Medical Device Problem Codes	Break (1069); Positioning Failure (1158); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The sample was returned to the manufacturer for inspection/evaluation.The investigation of the reported event is currently underway.H10: d4 (expiration date: 02/2026).H11: section a through f ¿ the information provided 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 that prior to a stent graft placement procedure, the red safety lock allegedly had broken.The procedure was completed using another device.There was no patient contact.
Additional Manufacturer Narrative
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 returned, and the outer part of the safety lock slider was found separated from the inner part of the safety slider at the welding joint; the stent was found correctly loaded, and the system was correctly locked inside grip.Based on the investigation of the provided information, the investigation is closed as confirmed for separation of the safety slider at the welding joint so that deployment was not possible.Labeling review: in reviewing the relevant labeling for this product, the potential issue was found addressed.The ifu state: 'prior to covered stent deployment, unlock the red safety lock by pressing down and pulling it back towards the end of the grip from the locked position into the unlocked position.Ensure that the red safety lock is completely retracted and that the symbol for the unlocked position is fully visible.' the ifu further state: 'after removal from the packaging, verify that the safety lock is in the locked position.Examine the packaging and delivery system to determine whether there is any damage or whether the sterile barrier has been compromised.Do not use the device if any of these conditions are observed.' h11: section a through f ¿ the information provided 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 that prior to a stent graft placement procedure, the red safety lock allegedly had broken.The procedure was completed using another device.There was no patient contact.
Additional Manufacturer Narrative
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 returned, and the outer part of the safety lock slider was found separated from the inner part of the safety slider at the welding joint; the stent was found correctly loaded, and the system was correctly locked inside grip.Based on the investigation of the provided information, the investigation is closed as confirmed for separation of the safety slider at the welding joint so that deployment was not possible.Labeling review: in reviewing the relevant labeling for this product, the potential issue was found addressed.The instructions for use state: 'prior to covered stent deployment, unlock the red safety lock by pressing down and pulling it back towards the end of the grip from the locked position into the unlocked position.Ensure that the red safety lock is completely retracted and that the symbol for the unlocked position is fully visible.' the instructions for use further state: 'after removal from the packaging, verify that the safety lock is in the locked position.Examine the packaging and delivery system to determine whether there is any damage or whether the sterile barrier has been compromised.Do not use the device if any of these conditions are observed.' h11: section a through f ¿ the information provided 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 that during a stent placement procedure, the safety slider broke before deployment so that a deployment was not possible.Reportedly, damage was not identified before use.The system was withdrawn, and another product was used for treatment.There was no reported patient injury.

• 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: 20522349
• Report Number: 9681442-2024-00372
• Device Sequence Number: 9105440
• Product Code: PFV
• UDI-Device Identifier: 00801741106293
• UDI-Public: (01)00801741106293(17)260215(10)ANJP2288
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P170042
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/11/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/15/2026
• Device Catalogue Number: AVSM08060
• Device Lot Number: ANJP2288
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2024
• Supplement Date Received by Manufacturer: 01/16/2025; 02/11/2025
• Initial Report FDA Received Date: 10/24/2024
• Supplement Report FDA Received Date: 01/28/2025; 02/18/2025
• 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
• Patient Age: 82 YR
• Patient Sex: Female