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

Model Number	85451
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/15/2016
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
As the physician was pushing the stent over the wire the stent came loose and was off the balloon.
Additional Manufacturer Narrative
Summary: the device in question was not returned therefore a proper investigation could not be performed.The details state that the stent was loose when the doctor was pushing the stent over the wire almost to the valve of the sheath; the stent came loose and was off the balloon.Atrium medical 100% inspects every device to ensure the stent was properly crimped in manufacturing.The device history records indicate that the crimped stent diameters of the 59 samples measured were within the proper range.In addition all 59 samples are placed through a 6fr introducer sheath prior to deploying the stents.This is conducted as part of the lot qualification performance testing.The likelihood that a stent was not crimped or properly crimped is extremely low.Without the device in question the crimped stent diameter cannot be verified.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.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.The instructions for use specify the following: "special care must be taken not to handle or in any way disrupt the placement of the icast covered stent on the balloon.This is most important during catheter removal from the packaging, placement over the wire guide and advancement through the bronchoscope or endotracheal tube." clinical evaluation: there are several possibilities that can cause stent dislodgement including but not limited to manipulation of the stent prior to use, overuse of the sheath causing failure of the hemostatic valve and a hemostatic valve that is too tight.If personnel at the table were unfamiliar with the device and attempted to hand crimp or manipulate the product in any way prior to use it could interrupt the integrity of the stent.If other devices were passed through the sheath prior to the stent it is possible that the valve lost integrity and failed for that reason.If the sheath was inserted without the use of the enclosed obturator the hemostatic valve was potentially too tight for a first pass with the stent.This event may be associated with a delay in treatment.

• 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: 6197804
• Report Number: 1219977-2016-00258
• Device Sequence Number: 19051551
• Product Code: JCT
• UDI-Device Identifier: 00650862854510
• UDI-Public: 00650862854510
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 12/15/2016

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: 10/31/2017
• Device Model Number: 85451
• Device Catalogue Number: 85451
• Device Lot Number: 217998
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/15/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/22/2016
• Supplement Report FDA Received Date: 01/11/2017
• 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: 74 YR