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

Device Problem Fluid/Blood Leak (1250)

Patient Problem Blood Loss (2597)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Article received: ertugay, s.E.(2020).Chimney technique for solitary pelvic kidney.Interactive cardiovascular and thoracic surgery, 743-744.Purpose: in this report, we present chimney graft implantation in a patient with solitary pelvic kidney.Method: a case study.Conclusion: good patency of the chimney graft was documented with early postoperative and first month scans.Per the article adverse events included: type ii endoleak ¿ not requiring intervention.

Event Description

N/a.

Manufacturer Narrative

This complaint is based on information within an article and no specific device information has been provided.As there is insufficient details of an actual device malfunction or adverse event that occurred the complaint cannot be confirmed.Conclusion: considering that getinge¿s advanta v12tm balloon expandable covered stents were successfully implanted using chimney technique to optimize the proximal landing zone for the renal artery, one can infer that device performed as expected.The authors do not attribute development of postoperative type ii endoleak to the implanted stents.H3 other text: product not available.

• 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: 11359078
• MDR Text Key: 232855553
• Report Number: 3011175548-2021-00200
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: TU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/30/2022

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/08/2021
• Initial Date FDA Received: 02/22/2021
• Supplement Dates Manufacturer Received: 06/28/2022
• Supplement Dates FDA Received: 06/30/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male