MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION GRAFTS ADVANTA VS; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

Model Number 21664

Device Problem Material Twisted/Bent (2981)

Patient Problem Hematoma (1884)

Event Date 09/18/2019

Event Type  Injury  

Manufacturer Narrative

Upon completion of the investigation into this event a follow up report will be submitted.

Event Description

Doctor stated: from (b)(6) 2019, a tumor was found in the thigh.It gradually increased, and ct was performed at the time of consultation in (b)(6) 2019.A hematoma was observed around the artificial blood vessel.On (b)(6) 2019, the aneurysm was incised under general anesthesia and a large amount of hematoma was removed.Two damaged parts were found in the artificial blood vessel, and they were judged to be bleeding sources.After the operation, the doctor requested a histopathological examination through in-hospital procedures, but the location of the excised and preserved artificial blood vessel was unknown.Since the doctor found an artificial blood vessel that had been removed and preserved, the doctor requested an analysis of the artificial blood vessel.Detailed observations (structural changes) of damaged artificial blood vessels are desired.

Manufacturer Narrative

Investigation: this complaint reports that a hematoma was observed around an advanta vs graft (p/n 21664) in a ct scan of a patient after having a tumor removed from their thigh.This graft was implanted on (b)(6), 2006 and was explanted on (b)(6) 2019.Two sites on the graft were determined to be damaged and sources of bleeding.The hospital lost track of the graft during their own inspection and it was not found again until april 2023, when it was reported to getinge.It is not known why the customer did not report the incident when it first occurred.Several requests were made to the customer for additional information and no response was received.The device has not been returned and no photographs have been provided.A medical assessment was completed.It noted that that the original patient diagnosis and the exact positioning of the graft is not known.It is also not known what procedures may have been performed on the graft in the 13+ years it was implanted.The medical assessment concluded this: "after review of limited provided information, as well as review of the published clinical literature, that clearly highlights the possible risks and complications known to occur during vascular graft implantation, one can infer that the described event is potentially multifactorial and getinge¿s advanta¿ vs standard wall vascular graft was not the sole attributing factor." the dhr for lot ae34104 was reviewed and no anomalies in manufacturing were found.There is no information to suggest this complaint is related to manufacturing, materials, or equipment.The ifu provides adequate instructions, warnings and precautions for the use of this device.It provides the user with a number of warnings to help prevent tearing or delamination of the graft.Advanta vs devices have been discontinued and are no longer included in monthly complaint trending.There have been no other complaints involving advanta vs devices in the past 15 months.A complaint history review was completed which found no similar complaints.A recurring lot number review was completed which identified no other complaints involving lot ae34104.A review of crs/capas found none related to this complaint.The user did not provide any evidence, photographs, or return the device for evaluation, so the complaint cannot be confirmed.No evidence was found in the investigation to support there being a device nonconformance.Not enough information is available to determine a definite root-cause.The root-cause of this complaint is impossible to define.The risk documents applicable to this product appropriately address the risk of this complaint.There have been no other complaints involving advanta vs in the past 15 months.Neither the complaint nor a device nonconformance can be confirmed.This graft was successfully implanted for over 13 years and no information is available about its treatment in that time.This incident occurred following a surgery which may well have been the cause, although that cannot be confirmed.The medical assessment concluded that there were likely multiple factors responsible for this incident and it is unlikely that the graft was the sole contributor.H3 other text : device not returned.

Manufacturer Narrative

Additional information: section a2 corrected information: section h10 revised investigation: this complaint reports that a hematoma was observed around an advanta vs graft (p/n (b)(4)).This graft was implanted on (b)(6) 2006 and was explanted on (b)(6) 2019.The helix was found to be detached from the graft and loosely wound around the graft while implanted.Two sites on the graft were determined to be damaged and sources of bleeding which formed the hematoma.The damaged parts of the graft were removed and a new graft was placed.There were no issues with suturing to the old graft material.The hospital lost track of the graft during their own inspection and it was not found again until (b)(6) 2023, when it was reported to getinge.It is not known why the customer did not report the incident when it first occurred.The device has not been returned.The customer did provide a drawing of the device as well as pictures of the device and explantation surgery, all which can be seen in the medical assessment.As the advanta vs device is no longer in production and all units that were previously made have expired, there are no contemporaneous or companion samples available to evaluate.A medical assessment was completed.It noted that that the original patient diagnosis, medical history and comorbidities are not known.It is also not known what procedures may have been performed on the graft in the 13+ years it was implanted.The medical assessment concluded this: "after review of provided information, as well as review of the published clinical literature, that clearly highlights the possible risks and complications known to occur during vascular graft implantation, it is reasonable to infer that the described event likely resulted from a combination of factors.The utilization of getinge's advanta¿ vs standard wall vascular graft should not be isolated as the sole contributing factor." the complaint can be confirmed based on the provided pictures and the device damage that was described can also be confirmed, although there is no indication that the device was nonconforming when it was first implanted.A likely cause of this complaint is not apparent from the information provided by the customer.There is no information to suggest this complaint is related to manufacturing, materials, or equipment.The ifu provides adequate instructions, warnings and precautions for the use of this device.It provides the user with a number of warnings to help prevent tearing or delamination of the graft.Advanta vs devices have been discontinued and are no longer included in monthly complaint trending.There have been no other complaints involving advanta vs devices in the past 15 months.A complaint history review was completed which found no similar complaints.A recurring lot number review was completed which identified no other complaints involving lot ae34104.A review of crs/capas found none related to this complaint.The complaint is confirmed, although a cause of the device damage cannot be determined with the available information.No evidence was found in the investigation to support there being a device nonconformance when the device was implanted.The root-cause of this complaint is impossible to define.The risk documents applicable to this product appropriately address the risk of this complaint.There have been no other complaints involving advanta vs in the past 15 months.This graft was successfully implanted for over 13 years and no information is available about its treatment in that time.This device is no longer in production and no changes will be made to its design, manufacturing, or risk documentation.The medical assessment concluded that there were likely multiple factors responsible for this incident and it is unlikely that the graft was the sole contributor.

Event Description

N/a.

• Brand Name: GRAFTS ADVANTA VS
• Type of Device: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH
• Manufacturer Contact: lori gosselin ; 40 continental blvd; merrimack, NH
• MDR Report Key: 16910665
• MDR Text Key: 314988727
• Report Number: 3011175548-2023-00106
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K992443
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2011
• Device Model Number: 21664
• Device Catalogue Number: 21664
• Device Lot Number: AE34104
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/30/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/31/2005
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male