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

Model Number 85420

Device Problem Material Separation (1562)

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

Event Date 03/22/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Balloon separated from the catheter during removal in the sheath after the stent had been deployed.The balloon was removed safely.

Manufacturer Narrative

Engineering investigation: the returned device was disinfected and evaluated to determine the cause of the complaint.Upon inspection the balloon had become completely detached from the catheter shaft.The catheter shaft had been necked down to a smaller diameter prior to the balloon detaching.This necked down area was measured and found to be.044"in.The shaft diameter at this location is typically.071"in.The balloon had been deployed during the procedure and was folded down from being in the introducer sheath.The proximal balloon bond was fully intact.The break occurred at the thermal balloon weld.During the in-process lot qualification testing the proximal balloon bond is tested to ensure the integrity of the welded joint.On this particular lot of catheters 20 samples were destructively proximal balloon bond tested.The lowest bond tensile force noticed was 24.4 newton's.The average bond tensile force was 29.0 newton's.The acceptance criterion for this bond strength is no tensile value blow 15 newton's.The introducer sheath used in the case was not returned.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.Clinical evaluation: there are several possibilities that could cause a component to break during a procedure, including getting caught on a piece of plaque or calcified lesion, or getting hung up on a previously placed device.If excessive force is used to withdraw a delivery catheter and the balloon breaks off it could cause an obstruction in the artery resulting in ischemia.The procedure may be prolonged while the broken component is snared and removed.The instructions for use (ifu) state that this device is contraindicated in non-compliant obstructions where full expansion of a balloon dilatation catheter cannot be achieved during pre-dilation, or where obstructions cannot be dilated sufficiently to allow passage or withdrawal of the delivery catheter.The ifu also warns "do not force passage or withdrawal of the guide-wire or delivery system if resistance is encountered.".

• Brand Name: ATRIUM ICAST COVERED STENT
• Type of Device: PTFE COVERED STENT
• Manufacturer (Section D): ATRIUM MEDICAL CORPROATION; 40 continental blvd; merrimack NH 03054
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 5 wentworth drive; hudson NH 03051
• Manufacturer Contact: lynda mclaughlin rn, ccrn-k ; 40 continental blvd; merrimack, NH 03054 ; 6038645470
• MDR Report Key: 6439169
• MDR Text Key: 71015104
• Report Number: 1219977-2017-00046
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/28/2017

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
• Device Operator: Physician
• Device Expiration Date: 10/27/2019
• Device Model Number: 85420
• Device Catalogue Number: 85420
• Device Lot Number: 244457
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/27/2017
• Initial Date FDA Received: 03/28/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/27/2016
• 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: 92 YR