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

Model Number 85442

Device Problem Device Slipped (1584)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/21/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The physician was trying to place the stent through the diaphragm of a 6fr sheath.The doctor pulled the stent out and the stent was loose off of the balloon.No harm to the patient.

Manufacturer Narrative

Engineering analysis: the returned device was removed from the bio-hazard bag and disinfected.Upon initial inspection the stent was shifted distally on the folded balloon.There were no signs of damage to the crimped stent or the folded balloon.The catheter shaft also showed no signs of damage.The stent did appear to have been properly crimped in manufacturing.The returned device balloon 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.The stent diameter was measured and was 2.2mm.This diameter is indicative of the 59 stents measured during the quality performance testing inspection.The diameter is slightly larger due to the stent being dislodged.The average crimped stent diameter of the 59 samples was 2.1mm.The introducer sheath used in this case was not returned.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 atrium's 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).· proximal balloon weld tensile testing.· distal tip tensile testing.Result: all quality inspection samples passed this final inspection without any non-conformances noted during the final lot qualification testing.During the review of the lot history records for this particular lot of catheters, the final lot qualification data shows that the 59 test samples were able to pass through the 6fr introducer sheath without any movement of the stent while advancing the delivery system through the sheath.Since december of 2013 over 30,000 test units have been passed through the introducer sheaths without a failure for stent movement.The product in question has also been subjected to simulated use in a tortuous iliac artery model whereas the stent delivery system is advanced contra laterally over the iliac arch through a 6fr 55cm long cook check flow performer introducer sheath.The stent is then deployed at nominal pressure as specified on the product label and the balloon deflated and withdrawn back through the introducer sheath.This testing was conducted numerous times while being submerged in a heated water bath at 37°c (body temperature) during design verification testing of the product.None of the samples tested had an issue regarding stent securement 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 can cause stent dislodgement including but not limited to manipulation of the stent prior to use, overuse of the sheath causing failure of the hemostatic valve or a hemostatic valve that is too tight.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 state that, "special care must be taken not to handle or in any way disrupt the placement of the icast stent on the balloon." if other devices were passed through the sheath prior to the stent it is possible that the valve lost integrity and failed for that reason.If the sheath was inserted without the use of the enclosed obturator the hemostatic valve was potentially too tight for a first pass with the stent.

• 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: 5846265
• MDR Text Key: 51134945
• Report Number: 1219977-2016-00169
• Device Sequence Number: 1
• Product Code: JCT
• UDI-Device Identifier: 00650862854428
• UDI-Public: 00650862854428
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 07/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 06/30/2018
• Device Model Number: 85442
• Device Catalogue Number: 85442
• Device Lot Number: 224679
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/04/2015
• 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