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

Model Number	85416
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/01/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On completion of the investigation a follow up report will be submitted.
Event or Problem Description
During preparation of this icast stent, the scrub tech attempted to flush the wire lumen port but was unable to push saline through.The physician set the device aside and used another stent without issue.
Additional Manufacturer Narrative
Engineering analysis: the returned device was removed from the bio-hazard bag and disinfected.Upon initial inspection the stent was still in its original position and firmly crimped to the balloon.The details of the case indicate that the physician was unable to flush the guide wire lumen with saline.In an attempt to determine the cause of the complaint a 20cc insufflator was filled with water and attached to the guide wire lumen port of the manifold and the syringe barrel was compressed.The lumen was unable to be flushed confirming the physician's findings.A 0.035 guidewire was then advanced through the distal tip of the guide wire lumen where a blockage was noticed under the stent within the guide wire lumen.The 0.035 wire was removed and placed through the guide wire lumen of the hub/manifold of the delivery system.A blockage was again noted approximately 3.0" from the proximal balloon weld.This production lot of catheters consisted of 82 catheter units.In an attempt to obtain more test units from the same lot of catheters a warehouse inventory search was conducted.The inventory data base shows that there are no more devices from this lot available.Based on the popularity of this particular stent size the probability that all devices have been consumed are very high.That said no other complaints for this particular lot of catheters have been received to date.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 atrium's 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.Clinical evaluation: if a delivery catheter has an occluded lumen, the physician will be unable to inflate the stent balloon to deploy the stent.In preparation for all interventional procedures the product, that is intended to be used, is prepared very specifically prior to entry onto the procedure table.The instructions for use advise to prime the catheter and balloon by flushing the guidewire lumen of the catheter so as to remove all apparent air from the catheter lumen.If the lumen is not able to be flushed it would reliably be discovered during this preparation and the product would be rejected.

• 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: 5851435
• Report Number: 1219977-2016-00178
• Device Sequence Number: 1281672
• Product Code: JCT
• UDI-Device Identifier: 00650862854169
• UDI-Public: 00650862854169
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2016

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: Physician
• Device Expiration Date: 04/20/2019
• Device Model Number: 85416
• Device Catalogue Number: 85416
• Device Lot Number: 237236
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/01/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/05/2016
• Supplement Report FDA Received Date: 09/02/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1