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

Model Number 85445

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/02/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the physician was delivering a stent to the superior mesenteric artery and the stent came off the balloon within the sheath.The physician then retracted the sheath, stent and balloon.Another stent was then successfully delivered.No harm to the patient.

Manufacturer Narrative

Engineering investigation: the device in question upon initial inspection did not have the stent.Only the delivery catheter was returned.All packaged materials were carefully inspected to ensure it had not been lost elsewhere in the packaging.The returned device balloon was still in the folded position as the balloon did not appear to be inflated.The 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.This includes passing the device through the labeled introducer sheath.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: the icast covered stent is indicated for the treatment of tracheobronchial strictures produced by malignant neoplasms.It is frequently used for vascular applications to open and support renal and iliac arteries.A stent can become dislodged if the vessel has calcification or severe disease or if the vessel has not been properly pre-dilated.Severely diseased arteries are difficult to access and the lesions can be very tight.Care must be taken to prevent further harm to the patient by applying excessive force in advancement and manipulation of the device.The instructions for use (ifu) warn to not use the icast covered stent in a non-compliant lesion where full expansion of the balloon dilatation catheter, appropriately sized for the lumen, cannot be obtained.The ifu also warns that special care must be taken not to handle or in any way disrupt the placement of the stent on the balloon.

• 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 rn, ccrn-k ; 40 continental blvd; merrimack, NH 03054 ; 6038645470
• MDR Report Key: 6414410
• MDR Text Key: 70251075
• Report Number: 1219977-2017-00035
• Device Sequence Number: 1
• Product Code: JCT
• UDI-Device Identifier: 00650862854459
• UDI-Public: 00650862854459
• 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: 03/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 02/06/2020
• Device Model Number: 85445
• Device Catalogue Number: 85445
• Device Lot Number: 245475
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/06/2017
• 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: 76 YR
• Patient Weight: 63