MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION ATRIUM ICAST COVERED STENT; PTFE COVERED STENT

Model Number	85419
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/29/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On completion of the investigation a follow up report will be submitted.
Event or Problem Description
During an endovascular aneurysm repair with subclavian approach to deliver the stents.While attempting to deliver the stent to the left hypogastric artery the shaft accordianed/crumbled.There were no acute angles but there was resistance.The device was in the sheath when this occurred and it was removed and discarded.No harm came to the patient.
Additional Manufacturer Narrative
Engineering analysis: as the device in question was not returned a proper investigation could not be conducted.The questions that were asked of the staff also went unanswered.A full review of the lot history inspection records and performance testing records indicate that this lot of catheters passed all requirements.The extrusion/catheter shaft dimensions from the device history records were reviewed and all shaft dimensions were within specification.Measurements include the shaft diameter, guidewire diameter, inflation lumen diameters and wall thickness requirements.The sheath used in the case was also not returned.The icast instructions for use specify the following caution."if resistance is encountered, do not force passage" engineering summary: a full review of the catheter lot history records for the device in question was performed.The records indicate that this lot of catheters passed atriums final lot qualification testing.This inspection requires that the catheter lot must pass the following: · ability of the stent and delivery system to be passed through the labeled introducer sheath.· ability to deploy the stent at nominal pressure (8atm).· ability to withdraw the deflated balloon catheter back through the labeled introducer sheath.· ability of the delivery system to withstand 5 inflate/deflate cycles at the rated burst pressure (12atm) without leaks or failures.· balloon burst testing.The balloon must burst over the rated burst pressure specified on the label (12atm).Result: all quality inspection samples passed this final inspection without any non-conformances noted during the final lot qualification testing.Conclusion: based on the details of the event and the successful lot qualification test data, atrium can find no fault with the device and or lot of stent delivery systems in question.It is possible that the icast got blocked by one of the other stents used in the case or the endograft itself.Clinical evaluation: arterial disease is usually caused by a build-up of fatty deposits on the walls of the arteries.Ischemia is a restriction in blood supply to tissues caused by an occlusion and resulting in a shortage of oxygen needed at the cellular level.Percutaneous transluminal angioplasty (pta) and stenting are frequently done to treat vascular occlusions with the intention of restoring blood flow through the occluded the instructions for use recommend that "special care should be taken to ensure that the appropriate size device, guide wire and sheath are selected prior to introduction.Native lumen dimensions must be accurately measured not estimated." there are several possibilities that can cause difficulty while advancing the delivery catheter including but not limited to an incorrectly sized sheath for the product and difficult anatomy.

• Brand Name: ATRIUM ICAST COVERED STENT
• Common Device Name: PTFE COVERED STENT
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 5 wentworth drive; hudson NH 03051
• MDR Report Key: 6157573
• Report Number: 1219977-2016-00248
• Device Sequence Number: 16322707
• Product Code: JCT
• UDI-Device Identifier: 00650862854190
• UDI-Public: 00650862854190
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K050814
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2016

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
• Operator of Device: Physician
• Device Expiration Date: 02/23/2019
• Device Model Number: 85419
• Device Catalogue Number: 85419
• Device Lot Number: 235443
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/29/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/09/2016
• Supplement Report FDA Received Date: 01/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AMPLATZ GUIDE WIRE; ANSEL INTRODUCER SHEATH
• Outcome Attributed to Adverse Event: Required Intervention