MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION ATRIUM ICAST COVERED STENT; PROSTHESIS, TRACHEAL, EXPANDABLE

Model Number 85455

Device Problem Device Slipped (1584)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/02/2015

Event Type  Injury  

Event Description

The surgeon was trying to advance the catheter through a 7 fr cook ansel sheath during a fenestrated graft case.The tip of the catheter had penetrated the introducer sheath but the stent slid off as it was being passed through the hub.

Manufacturer Narrative

On completion of the investigation a follow up report will be submitted.Associated file: mdr 1219977-2015-00179.

Manufacturer Narrative

Engineering analysis: the complaint details provided indicate that the stent dislodged off the balloon on insertion through the introducer sheath.The introducer sheath used in this case was not returned.The complaint details also mentioned that there were two devices used in the procedure but were not sure which of the two devices had the stent dislodgement.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.The introducer sheath used in the case was not returned.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 10 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) manifold to shaft tensile testing.Samples when tensile tested must not break or separate below 3.37lbs result: all (b)(4) quality inspection samples passed this final inspection without any non-conformances noted during the final lot qualification testing related to the stent.All samples passed through the introducer sheath without any stent dislodgments.Conclusion: based on the details of the event and the successful lot qualification test data, atrium can find no fault with the device and or lot of stent delivery systems in question.

Event Description

Follow up.

• Brand Name: ATRIUM ICAST COVERED STENT
• Type of Device: PROSTHESIS, TRACHEAL, EXPANDABLE
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; hudson NH
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 5 wentworth drive; hudson NH 03051
• Manufacturer Contact: lynda mclaughlin ; 5 wentworth drive; hudson, NH 03051 ; 6038645470
• MDR Report Key: 4899491
• MDR Text Key: 22243290
• Report Number: 1219977-2015-00181
• Device Sequence Number: 1
• Product Code: JCT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050814
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 85455
• Device Catalogue Number: 85455
• Device Lot Number: 221327
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 7 FR COOK ANSEL SHEATH
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR