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

Model Number 85441

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 06/23/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).On completion of the investigation, a follow up report will be submitted.

Event Description

Medwatch received from fda.The stent on the delivery catheter fell off or slipped off the balloon after the device was opened onto the sterile field.This occurred prior to trying to implant the device in the patient.

Manufacturer Narrative

Engineering investigation: the returned device was evaluated to determine the cause of the complaint."the stent on the delivery catheter fell off or slipped off the balloon after the device was opened onto the sterile field.This occurred prior to trying to implant the device in the patient".Upon inspection the stent was firmly crimped in its original position between the two gold radiopaque marker bands.The catheter stent and delivery system were completely blood stained and had been inside the patient.The crimped stent diameter was measured and was 2.1mm.This diameter is indicative of the product when properly crimped.To determine if the device was still functional the catheter was prepped per the instructions for use.Upon initial inflation a pin hole leak was noticed in the distal balloon cone.It is not clear how the balloon had become damaged based on the complaint details.Being that this device was used in conjunction with a fenestrated endograft it is possible that the balloon came in contact with a fixation barb of the endograft or possibly on a sharp calcified lesion.A review of the device history records show that the minimum balloon burst volume was 19.4atm.This is well above the requirement of 12atm as specified on the product label.In addition to the burst value far exceeding the product requirement the stent retention test values were evaluated and the minimum stent dislodgment force seen was 8.5newtons (n).This also far exceeds the product requirement of a minimum of 2.9n.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 associated with the complaint.There were no issues in regards to the stents being able to pass through the introducer sheath.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.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.It is unclear how the balloon became damaged based on the complaint details; however the returned product did not resemble the complaint description whereas the stent was still properly crimped to the catheter.Clinical evaluation: endovascular aortic aneurysm repair (evar) is a minimally invasive procedure that is used to treat an abdominal aortic aneurysm.The procedure includes placement of a large endograft within the aorta and stent placement into the adjacent arteries as protection from occlusion by the graft.The graft is then secured via fixation barbs to prevent migration.If personnel at the table were unfamiliar with the device and attempted to hand crimp or manipulate the product in any way prior to use it could interrupt the integrity of the stent.The instructions for use (ifu) warn that special care must be taken not to handle or in any way disrupt the placement of the icast covered stent on the balloon.

• Brand Name: ICAST COVERED STENT
• Type of Device: PTFE COVERED STENT
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack 03054
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack 03054
• Manufacturer Contact: lynda mclaughlin ; 40 continental blvd; merrimack, NH 03054
• MDR Report Key: 6844419
• MDR Text Key: 85626541
• Report Number: 3011175548-2017-00117
• Device Sequence Number: 1
• Product Code: JCT
• UDI-Device Identifier: 00650862854411
• UDI-Public: 00650862854411
• 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,other
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 12/05/2019
• Device Model Number: 85441
• Device Catalogue Number: 85441
• Device Lot Number: 244961
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2016
• 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 Age: 81 YR
• Patient Weight: 97