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

Model Number 85440

Device Problem Device Slipped (1584)

Patient Problem No Information (3190)

Event Date 09/30/2015

Event Type  Injury  

Manufacturer Narrative

On completion of the investigation a follow up report will be submitted.

Event Description

The stent slipped off the balloon as it was advanced into the sheath.

Manufacturer Narrative

Engineering analysis: the complaint details provided indicate that the stent dislodged off the balloon within the introducer sheath.The returned device balloon surface was evaluated to determine if the stent was crimped properly during manufacturing.The crimped stent impressions were clearly visible indicating that the stent was properly crimped during manufacturing.The crimped stent diameter was measured and was 2.14mm.This diameter when compared to the lot qualification test data and falls within the same range of diameters that are only slightly smaller.The slightly larger diameter is due to the stent being pulled over the folded balloon cones.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 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 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 59 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.During the final lot qualification data shows that all 59 test samples were able to pass through the 6fr introducer sheath without issue.Since december of 2013 over 30,000 test units have been passed through the introducer sheath without a failure for the inability of the stent to pass through the introducer sheath.The product in question has also been subjected to simulated use in a tortuous iliac artery model whereas the stent delivery system is advanced contra laterally over the iliac arch through a 6fr 55cm long cook check flow performer introducer sheath.The stent is then deployed at nominal pressure as specified on the product label and the balloon deflated and withdrawn back through the introducer sheath.This testing was conducted numerous times while being submerged in a heated water bath at 37°c (body temperature) during design verification testing of the product.None of the samples tested had an issue regarding stent dislodgments while passing through the introducer sheath.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.

• Brand Name: ATRIUM ICAST COVERED STENT
• Type of Device: PTFE COVERED STENT
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 5 wentworth drive; hudson NH 03051
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 5 wentworth drive; hudson NH 03051
• Manufacturer Contact: lynda mclaughlin ; 40 continental blvd.; merrimack, NH 03054 ; 6038645470
• MDR Report Key: 5155727
• MDR Text Key: 28457283
• Report Number: 1219977-2015-00305
• 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: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 07/31/2017
• Device Model Number: 85440
• Device Catalogue Number: 85440
• Device Lot Number: 211656
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/03/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR