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

Model Number	85450
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/21/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On completion of the investigation a follow up report will be submitted.Associated files: 1219977-2017-00028.
Event or Problem Description
The stent advanced through the hemostatic valve of the introducer and came off the balloon as it entered a cook 6fr sheath.
Additional Manufacturer Narrative
Additional information: sex.Engineering investigation: the device in question was received and disinfected.The stent was no longer in place on the balloon.The stent diameter was measured and was 2.1 mm.This diameter is indicative of a properly crimped stent and matches the data of the other properly crimped devices from the same lot as indicated on the quality inspection data sheets.The returned device balloon surface was evaluated to determine if the stent was crimped properly during manufacturing, when the stent is crimped on to the folded balloon the stent frame leaves impressions of the stent frame on the surface of the balloon.The impressions indicate if the stent was properly crimped on to the balloon.The crimped stent impressions were clearly visible indicating that the stent was properly crimped during manufacturing.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.The introducer sheath used in the case was not returned.If the sheath had been returned it would have been inspected for kinking or damage that may have hindered the ability of the catheter to be advanced further.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.Clinical evaluation: there are several possibilities that can cause stent dislodgement on entry into the sheath including, but not limited: ·manipulation of the stent prior to use - 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.·overuse of the sheath causing failure of the hemostatic valve - 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.·a hemostatic valve that is too tight.- 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.The instructions for use state that, "special care must be taken not to handle or in any way disrupt the placement of the icast stent on the balloon.This is most important during catheter removal from packaging, placement over the wire guide and advancement through the introducer device.".

• 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: 6361150
• Report Number: 1219977-2017-00027
• Device Sequence Number: 10991255
• Product Code: JCT
• UDI-Device Identifier: 00650862854503
• UDI-Public: 00650862854503
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Report Date (Section B): 02/27/2017

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: 01/31/2018
• Device Model Number: 85450
• Device Catalogue Number: 85450
• Device Lot Number: 221073
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/22/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/27/2017
• Supplement Report FDA Received Date: 04/04/2017
• 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: COOK SHEATH 6 FR
• Outcome Attributed to Adverse Event: Required Intervention