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

Model Number 85404

Device Problem Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/20/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The physician placed the stent at the lesion site, and as he inflated the balloon, it ruptured.The stent was then post dilated to the 7 mm diameter with a second balloon.The case was successfully completed, and there were no further complications.The patient was not harmed.

Manufacturer Narrative

Analysis: the details provided indicate that the physician placed the stent at the lesion site, and as he inflated the balloon, it ruptured.No other details were provided.Upon inspection of the returned device the balloon appears to have been fully deployed.To determine the location of the failure in the balloon, the device was inflated with water.A 2cm long longitudinal tear was discovered in the dilatation zone that propagated into the distal balloon cone.Under magnification there were no signs of visible damage to the balloon in regards to scratches.It does appear that the rupture started in the distal balloon cone and propagated into the dilatation zone of the balloon.As none of the questions that were asked were answered, it is difficult to determine the root cause of the balloon rupture.If the device was used in conjunction with an endograft, the balloon may have ruptured on a fenestration ring or fixation barb.There is also a possibility that the lesion was extremely calcified causing the balloon to rupture upon inflation.Without more details from the case this cannot be confirmed.A full review of the catheter lot history records was performed.Below is an overview of the quality and performance criteria that every lot of icast covered stent systems is tested to.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) in addition to the final lot qualification testing there are multiple in-process inspections conducted that include the following: balloon hole skive dimensional verification.Stent securement testing.Proximal balloon weld tensile testing.Distal tip tensile testing.Catheter leak check.This lot of catheters passed all quality and performance criteria without any non-conformances related to the complaint.A review of the balloon burst performance data indicates that out of 49 balloon burst samples the lowest value observed was 19.6atm.This is far above the 12atm rated burst pressure as specified on the product label.Conclusion: based on the passing results of the quality and performance testing and the lack of details provided, atrium medical cannot determine the reason for the balloon rupture.

Manufacturer Narrative

Analysis: the details provided indicate that the physician placed the stent at the lesion site, and as he inflated the balloon, it ruptured.No other details were provided.Upon inspection of the returned device the balloon appears to have been fully deployed.To determine the location of the failure in the balloon, the device was inflated with water.A 2cm long longitudinal tear was discovered in the dilatation zone that propagated into the distal balloon cone.Under magnification there were no signs of visible damage to the balloon in regards to scratches.It does appear that the rupture started in the distal balloon cone and propagated into the dilatation zone of the balloon.As none of the questions that were asked were answered, it is difficult to determine the root cause of the balloon rupture.If the device was used in conjunction with an endograft, the balloon may have ruptured on a fenestration ring or fixation barb.There is also a possibility that the lesion was extremely calcified causing the balloon to rupture upon inflation.Without more details from the case this cannot be confirmed.A full review of the catheter lot history records was performed.Below is an overview of the quality and performance criteria that every lot of icast covered stent systems is tested to.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) in addition to the final lot qualification testing there are multiple in-process inspections conducted that include the following: balloon hole skive dimensional verification.Stent securement testing.Proximal balloon weld tensile testing.Distal tip tensile testing.Catheter leak check this lot of catheters passed all quality and performance criteria without any non-conformances related to the complaint.A review of the balloon burst performance data indicates that out of 49 balloon burst samples the lowest value observed was 19.6atm.This is far above the 12atm rated burst pressure as specified on the product label.Conclusion: based on the passing results of the quality and performance testing and the lack of details provided, atrium medical cannot determine the reason for the balloon rupture.

• Brand Name: ICAST COVERED STENT
• Type of Device: PROSTHESIS, TRACHEAL
• Manufacturer (Section D): ATRIUM MEDICAL; 40 continental blvd; merrimack NH 03054
• Manufacturer (Section G): ATRIUM MEDICAL; 40 continental blvd; merrimack NH 03054
• Manufacturer Contact: 40 continental blvd; merrimack, NH 03054
• MDR Report Key: 7161889
• MDR Text Key: 96332276
• Report Number: 3011175548-2018-00005
• Device Sequence Number: 1
• Product Code: JCT
• Combination Product (y/n): N
• PMA/PMN Number: K050814
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/22/2020
• Device Model Number: 85404
• Device Catalogue Number: 85404
• Device Lot Number: 248844
• Other Device ID Number: 00650862854046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2018
• Date Manufacturer Received: 02/12/2018
• 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