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

Model Number 85405

Device Problems Inadequacy of Device Shape and/or Size (1583); Fitting Problem (2183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/21/2015

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that during an elective case, the physician was using a covered stent with a shaft length of 80 cm, but he felt it was shorter than 80 cm as he came up short to his target.He had to use a product with a longer shaft.No harm to the patient.

Manufacturer Narrative

Engineering analysis: the sample was removed from the bio-hazard bag and inspected to determine the cause of the complaint.The details provided indicated that the catheter was not 80cm as indicated upon the product label and when measured against a separate competitor's 75cm catheter was even shorter than the 75cm device.The returned device was removed from the bio-hazard bag and measured using a 120cm long ruler.The actual length on the catheter measured from the end of the strain relief to the distal tip of the catheter was 76mm.This length based upon the atrium medical internal specifications is within the internal specification of 80cm +/- 5cm.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.Conclusion: as this icast catheter was not at the nominal length of 80cm the device was still within atrium medicals usable length specification.All devices are measured 100% during the manufacture of the device.Any device found to be shorter than 75cm is scrapped and not used.

• 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: 5113355
• MDR Text Key: 27094915
• Report Number: 1219977-2015-00288
• 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: 09/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 08/31/2018
• Device Model Number: 85405
• Device Catalogue Number: 85405
• Device Lot Number: 228219
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/20/2015
• 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: 74 YR