MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION ADVANTA V12 COVERED STENT; STENT, ILIAC

Device Problem Insufficient Information (3190)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Event Description

Article received: behr, c.E.(2020).Minimal invasive removal of a dislocated stent for flow reduction of a transjugular intrahepatic portosystemic shunt.Objective: to present a case study.Method: a case study of a patient with advanced liver cirrhosis requiring a tips procedure utilizing an advanta v12 covered stent.Conclusions: tips revisions are challenging procedures and rarely entail complications such as dislocations.This case illustrates the need for a wide range of equipment if these procedures go awry.Per the article product problems included insufficient deployment, stent migration.

Manufacturer Narrative

On completion of the investigation a follow up report will be submitted.

Manufacturer Narrative

Article reviewed: behr, c.E.(2020).Minimal invasive removal of a dislocated stent for flow reduction of a transjugular intrahepatic portosystemic shunt.588-590.The subject article is a case report of a 59-year-old woman suffering from advanced liver cirrhosis who underwent transjugular intrahepatic portosystemic shunt (tips) insertion in 2014 followed by revision in 2015.As a side effect she developed hepatic encephalopathy.Therefore, tips flow reduction using a covered stent and establishing an hourglass shape like configuration was performed in (b)(6) 2019.This complaint is based on information found within a article/literature review.There was no product that was available for evaluation, therefore a device evaluation could not be conducted and the complaint cannot be confirmed.The author of the article did not report any major adverse patient effects as result of this event.A device history record (dhr) review was unable to be performed as the device product part number and lot number was not provided within the article.Attempts to obtain the device lot information was conducted but unsuccessful.The hazardous situation/harm is addressed in the risk file and is operating within its risk profile.There was no evidence within the article that the device was the cause of the reported event.The complaint history review did not identify an adverse trend, therefore no escalation to capa process is required.Conclusion: although it was a case report of a single patient and physicians utilized modified deployment technique with under-expansion of the stent, however the dislocation and migration of the stent graft are a major concern.Getinge advanta v12 stent migrated that could have cause major complications.According to the report the advanta v12 stent was successfully removed with a salvage maneuver.The author did not report any adverse patient effects as result of this event.

Event Description

N/a.

• Brand Name: ADVANTA V12 COVERED STENT
• Type of Device: STENT, ILIAC
• 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: 12858424
• MDR Text Key: 281136329
• Report Number: 3011175548-2021-01179
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/12/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female