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

Model Number	85417
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/30/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On completion of the investigation a follow up report will be submitted.Associated file 1219977-2016-00213.
Event or Problem Description
The physician was treating an endovascular aneurysm repair with an ovation stent graft.He was using a stent to preserve the patient's right hypogastric artery.As he was crossing the stent over the top of the graft he began to feel a lot of resistance.As he was advancing the device he said the shaft was bending.Ultimately he ended up removing the stent because he was not able to advance it any further.
Additional Manufacturer Narrative
Additional information: engineering analysis: upon opening the returned device packaging the contents included a.035 coated guidewire, a large 12fr introducer sheath and the product in question an icast 8mm x 59mm x 120cm stent delivery system.The contents were disinfected and inspected for damage.The guidewire was inspected and had many locations where the guidewire was bent.In one location approximately 140cm from the tip the wire was kinked.The introducer sheath used in the case was not damaged but the tip of the sheath was slightly deformed and the distal end of the sheath had a very large bend to it.The stent delivery system stent had a very large curve to it as well.The stent was securely in place between the two radio opaque ro marker bands.The crimped stent diameter was measured and was 2.5mm.This diameter when compared to the lot history records for crimped stent diameter is in line with the other devices from the same lot of crimped catheters.To determine if this returned device was still functional, the returned.035" guidewire was placed through the guidewire lumen of the catheter.There was significant resistance advancing the catheter over the guidewire as the guidewire was bent in multiple locations.The icast was then placed through the returned introducer sheath and the balloon prepped per the instructions for use that are supplied with the product.The balloon was inflated to a nominal pressure of 8atm successfully deploying the stent.The returned device was fully functional.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.The return details provided in the answers section of the complaint details indicates that when the question of if the delivery catheter got hung up on the ovation graft, the response was that the angle the delivery catheter had to track over was too acute.Based on the condition of the stent and the degree of bending seen it is probable that the angle was too much for the sheath, guidewire and delivery system.Conclusion: based on the details of the event and the successful lot qualification test data, atrium can find no fault with the lot of stent delivery systems in question.Associated file: 1219977-2016-00213.

• 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: 6002417
• Report Number: 1219977-2016-00212
• Device Sequence Number: 18856420
• Product Code: JCT
• UDI-Device Identifier: 00650862854176
• UDI-Public: 00650862854176
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2016

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: 08/30/2019
• Device Model Number: 85417
• Device Catalogue Number: 85417
• Device Lot Number: 242797
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/30/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/06/2016
• Supplement Report FDA Received Date: 11/09/2016
• 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: 7FR TERUMO DESTINATION SHEATH; OVATION STENT GRAFT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR