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

Model Number	85407
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/26/2017
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 the stent did not cross.There was no patient harm.
Additional Manufacturer Narrative
Engineering investigation: upon initial inspection the device appears to never have made patient contact.There were no biological fluids within the distal tip of the catheter or on the ptfe covered stent.If the device had been placed into the introducer sheath the device would have some staining.The stent was firmly in its original crimped position.The diameter of the stent was measured and was 2.4 mm.This diameter is indicative of a properly crimped stent.To ensure the integrity of the device in question the stent was deployed following the instructions for use to 8 atm.The stent deployed perfectly.The balloon pressure was then increased to the rated burst pressure of the balloon of 12 atm.The balloon held pressure and the stent was again perfect.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 (8 atm).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 (12 atm) without leaks or failures.Balloon burst testing.The balloon must burst over the rated burst pressure specified on the label (12 atm).Result: all quality inspection samples passed this final inspection without any non-conformances noted during the final lot qualification testing associated with the complaint.There were no issues in regards to the stents being able to pass through the introducer sheath.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.Result: all quality inspection samples passed this final inspection without any non-conformances noted during the final lot qualification testing.Conclusion: based on the results of this investigation the product in question was in perfect working order and showed no signs of actual use.Clinical evaluation: it may be difficult to advance a stent to the target lesion if the device was not sized correctly or if the lesion was not pre-dilated prior to advancing the stent.Also, total occlusions of a target must also be pretreated prior to attempting to advance the stent or the stent will not cross.The instructions for use (ifu) warn that special care should be taken to ensure that the appropriate size device is selected prior to introduction.Native lumen dimensions must be accurately measured, not estimated.The ifu also states use of the icast is contraindicated in non-compliant obstructions where full expansion of a balloon dilatation catheter cannot be achieved during pre-dilation, or where obstructions cannot be dilated sufficiently to allow passage of the delivery catheter.
Additional Manufacturer Narrative
Addendum: the investigation of the returned product revealed that the icast covered stent had never had patient contact, therefore the initial report of "did not cross" was incorrect.Clarification request was sent to the sales representative who contacted the physician.The physician disclosed that the device was not used, had never had patient contact and he was requesting a replacement.

• 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: 6575747
• Report Number: 1219977-2017-00060
• Device Sequence Number: 627641
• Product Code: JCT
• UDI-Device Identifier: 00650862854176
• UDI-Public: 00650862854176
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/18/2017

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: 01/20/2020
• Device Model Number: 85407
• Device Catalogue Number: 85407
• Device Lot Number: 249598
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/31/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/01/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided
• Initial Report FDA Received Date: 05/18/2017
• Supplement Report FDA Received Date: 06/08/2017; 06/12/2017; 06/13/2017
• 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
• Patient Age: 81 YR