MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION STENTS I-CAST; PROSTHESIS, TRACHEAL, EXPANDABLE

Model Number	85445
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Medwatch report received #(b)(4), description of events reports: "during an aorta, endovascular repair by deployment of a fenestrated visceral aortic endograft, "the device deployed as it was going into the oscor steerbale sheath, caught on the entrance section and deployed, placed through the left groin.".
Additional Manufacturer Narrative
Upon completion of the investigation into this event a follow up report will be submitted.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Additional information: section d9 & h6 corrected information: section h1 & h6 - clinical and impact code investigation: based on the details of the complaint the product in question had the stent dislodged while entering the oscor introducer sheath.There was no patient harm and that the procedure was completed using another icast stent.The sheath size used to deliver the endograft was described to have been a 12fr or greater oscor steerable introducer sheath.The sheath size used to deliver the icast covered stent was not provided.The recommended sheath size per the icast covered stent product label is 7fr.As the device in question was not returned the complaint cannot be confirmed.There were no images provided of the product in question and no fluoroscopic images from the case.The review of the device history records show that the affected lot of catheters passed all quality inspection requirements including stent retention testing (force required to dislodge the stent).In addition to stent retention testing a sampling of 13 devices as part of the lot performance qualification testing are passed through the labeled introducer sheath (7fr) and the stents inspected to ensure there was no movement of the stent while passing through the sheath and the stents deployed.The results as provided in the dhr show that all units passed this requirement, and the minimum stent retention value was 11.29 newtons.The stent retention force based on the part specification drawing ps010635-xxx revision ac is =5.5newtons.This requirement was exceeded.Based on the details of the complaint and lack of the product and introducer sheath used in the case the root cause is impossible to define.There is no evidence that the device in question was at fault.There is no evidence that equipment, process, materials, or design was the cause of the complaint as all indications suggest the product met product requirements.A complaint history, and complaint trend review did not identify any related complaints or trends to specifically aid in the investigation.The capa and cr review did not identify any related capa¿s or cr¿s where the stent had dislodged while entering the introducer sheath.A risk review found that the risk management documents for this product adequately address the reported defect and the severity and anticipated occurrence level are appropriate.A labeling review was conducted.The ifu was found to provide adequate instructions in regard to not force passage if resistance is encountered.H3 other text : device not available for return.

• Brand Name: STENTS I-CAST
• Common Device Name: PROSTHESIS, TRACHEAL, EXPANDABLE
• 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: 17804600
• Report Number: 3011175548-2023-00184
• Device Sequence Number: 12558557
• Product Code: JCT
• UDI-Device Identifier: 00650862854459
• UDI-Public: 00650862854459
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K050814
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2023

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: 09/24/2025
• Device Model Number: 85445
• Device Catalogue Number: 85445
• Device Lot Number: 489095
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2023
• Supplement Date Received by Manufacturer: 11/08/2023
• Initial Report FDA Received Date: 09/22/2023
• Supplement Report FDA Received Date: 11/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/26/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OSCOR STEERBALE SHEATH
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 98 KG