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

Model Number	85407
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/24/2014
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
It was reported that on 3-year follow up ct scan, a type iii endoleak at the overlap of the branch graft and the stent was noted.A type ii lumbar endoleak was also present within the infrarenal aneurysm sac.
Additional Manufacturer Narrative
Analysis: no product was returned.Based on the complaint details provided by the physician the overlap of the two stents was excellent and that the stent had been post dilated with a coda balloon.The physician also stated the following: "i do not think this is clinical significant and no further intervention or diagnostic study is indicated beyond what would be customary in the context of the clinical trial or routine postop surveillance".A full review of the catheter lot history records for the devices 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 associated with the complaint.The stent recoiled stent diameters after deployment to nominal pressure (8atm) were all within acceptable rages and meet the product requirements.In addition to the final lot qualification testing there are multiple in-process inspections conducted that include the following: balloon hole skive dimensional verification.Stent securement testing.Proximal balloon weld tensile testing.Distal tip tensile testing.Catheter leak check.Result: all quality inspection samples passed this final inspection without any non-conformances noted during the final lot qualification testing.Conclusion: a full review of all manufacturing lot history and sterilization records was performed and no deficiencies were noted during the review.Based on the passing results of the device history records review atrium medical cannot determine the root cause of the complaint related to a type iii endoleak.Clinical evaluation: an endoleak is a common complication of endovascular aneurysm repair and is found in patients intraoperatively and during follow-up.Endoleaks are often asymptomatic, however as flow within the aneurysm sac is at systemic or near- systemic pressure and left untreated, the aneurysm may expand and is at risk of rupture.The instructions for use (ifu) precaution that prior to completion of the procedure, utilize fluoroscopy to ensure proper positioning of the deployed stent.If the target stricture is not covered fully, use additional stents as necessary to adequately treat the stricture.The ifu also states complications and adverse events can occur when using any endoluminal device.These include, but are not limited to: misplacement, migration, infection, sepsis, occlusion, perforation or hemorrhage.

• Brand Name: ICAST COVERED STENT
• Common Device Name: PTFE COVERED STENT
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack 03054
• MDR Report Key: 6983669
• Report Number: 3011175548-2017-00219
• Device Sequence Number: 1197378
• Product Code: JCT
• UDI-Device Identifier: 00650862854077
• UDI-Public: 00650862854077
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K050814
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2017

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: 05/31/2017
• Device Model Number: 85407
• Device Catalogue Number: 85407
• Device Lot Number: 208372
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/26/2017
• Supplement Date Received by Manufacturer: 11/20/2017
• Initial Report FDA Received Date: 10/27/2017
• Supplement Report FDA Received Date: 11/21/2017
• 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: COOK ENDOGRAFT
• Outcome Attributed to Adverse Event: Required Intervention