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

Model Number 85353

Device Problems Failure to Advance (2524); No Apparent Adverse Event (3189)

Patient Problems Vascular Dissection (3160); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/29/2024

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Distributor stated: i have been informed by procurement that stent was "explanted".Informed by nurse that it was removed due to not being able to cross calcium at lesion.

Event Description

Additional information receive stated: the operational procedure was aortogram of the superior mesenteric artery and aorta and attempt at treatment of the superior mesenteric artery branch aneurysm.The operating clinician was contacted through his office staff.His reply when he was asked what the issue with the stent was - he said the stent wouldn't track to cover the origin of visceral aneurysm.Resistance was felt causing the sheath to be pushed out of the sma.Subsequent attempts to exchange wires resulted in the dislodgment of a key wire needed for stent placement.Angiographic runs revealed some spasm in the superior mesenteric artery and a potential small dissection.Procedure was terminated, and the patient was closely monitored postoperatively.Ultrasound scan the next day indicated good flow in the superior mesenteric artery.Future intervention planned.

• Brand Name: STENTS ADVANTA V12
• 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: 18712740
• MDR Text Key: 335481248
• Report Number: 3011175548-2024-00062
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 85353
• Device Catalogue Number: 85353
• Device Lot Number: 501271
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/05/2024
• Date Device Manufactured: 09/14/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN 6F SHEATH
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female