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

Model Number	85414
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/28/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On completion of the investigation a follow up report will be submitted.Associated files 1219977-2016-00215.
Event or Problem Description
The stent could not be implanted.
Additional Manufacturer Narrative
Engineering analysis: the icast was removed from the packaging and inspected to determine the cause of the complaint.The delivery system was decontaminated and inspected for damage.There was no damage seen.The stent was firmly in place between the two gold radio opaque ro marker bands.The stent had a slight curve to it but the stent was not damaged.The crimped stent diameter was measured and was 2.3mm.The dimension was compared to the data from the lot qualification samples.The diameter of 2.3mm is indicative of a properly crimped stent.To determine the functionality of the icast covered stent system the catheter was prepped per the instructions for use and the stent deployed to nominal inflation pressure (8atm).The stent opened properly and was properly positioned after deployed between the ro marker bands.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 10 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).Manifold to shaft tensile testing.Samples when tensile tested must not break or separate below 3.37lbs.Result: all (b)(4) quality inspection samples passed this final inspection without any non-conformances noted during the final lot qualification testing related to the stent.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.Clinical evaluation: a stent can become an obstruction by becoming dislodged while being advanced through a difficult area of disease and by being inaccurately sized.The instructions for use state, "special care should be taken to ensure that the appropriate size device, guide wire, compatible bronchoscope and endotracheal tube are selected prior to introduction.Native lumen dimensions must be accurately measured, not estimated.".

• 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: 6013520
• Report Number: 1219977-2016-00214
• Device Sequence Number: 16623557
• Product Code: JCT
• UDI-Device Identifier: 00650862854145
• UDI-Public: 00650862854145
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2016

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: 11/09/2018
• Device Model Number: 85414
• Device Catalogue Number: 85414
• Device Lot Number: 231388
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/29/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/10/2016
• Supplement Report FDA Received Date: 10/19/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention