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

Model Number 85417

Device Problem Deflation Problem (1149)

Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)

Event Date 08/13/2015

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the stent was deployed and the balloon would not deflate.The physician had to remove the balloon and sheath all together to get the stent balloon out.

Manufacturer Narrative

Engineering evaluation: the sample was removed from the bio-hazard bag and inspected to determine the cause of the complaint.On initial inspection the catheter had been removed from the introducer sheath and showed no signs of damage.The balloon was fully evacuated of all fluid.The balloon did not show any signs of stress at the proximal or distal balloon cones.There were also no signs of stress or stretching of the shaft at the proximal balloon bond thermal weld.The folded balloon was advanced back through the introducer sheath and there seemed to be some difficulty about 5cm distal of the valve of the introducer sheath.The sheath upon inspection appeared to be slightly deformed at this location.The balloon was still able to pass through but was notably different resistance was met at this location.The distal tip of the introducer sheath showed no signs of damage or stress related to the inability to withdraw the deflated balloon back through the introducer sheath.The instructions for use specify the following: "do not force passage or withdrawal of the guidewire or delivery system if resistance is encountered." it would appear that the introducer sheath deformity may have prohibited the balloon catheter from being withdrawn easily through the introducer sheath.It is also possible that the balloon was not allowed sufficient time to deflate prior to withdrawing back through the introducer sheath.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 (b)(4) quality inspection samples passed this final inspection without any non-conformances noted.All units were able to be withdrawn back through the introducer sheath without issue.Conclusion: atrium has been unable to determine that there was an issue with the device in question and have not been able to determine any fault due to manufacturing.

• Brand Name: ATRIUM ICAST COVERED STENT
• Type of Device: PROSTHESIS, TRACHEAL, EXPANDABLE
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; hudson NH 03051
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; hudson NH 03051
• Manufacturer Contact: lynda mclaughlin ; 10 continental blvd.; merrimack, NH 03054 ; 6038645470
• MDR Report Key: 5008282
• MDR Text Key: 23187696
• Report Number: 1219977-2015-00236
• 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: Followup
• Report Date: 08/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 07/31/2018
• Device Model Number: 85417
• Device Catalogue Number: 85417
• Device Lot Number: 226999
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2015
• 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: 75 YR