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

Model Number 85412

Device Problems Difficult to Insert (1316); Loose or Intermittent Connection (1371)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/09/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The physician was treating a mesenteric stenosis with a stent.He attempted to place a 7fr compatible stent into a 6fr cordis sheath.When the stent did not go into the sheath they upsized to a 7fr with a touey attachment on it and the stent again did not enter the sheath.They removed the attachment and attempted to introduce the stent again when it was noticed that the stent was loose on the balloon.

Manufacturer Narrative

Engineering investigation: the device in question upon initial inspection had the stent dislodged in the distal direction toward the distal tip.The crimped stent diameter was measured and was 2.3mm.This diameter is indicative of the (b)(4) stents measured during the quality performance testing inspection.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.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 (b)(4) 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 7fr 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: mesenteric artery stenosis results in insufficient blood flow to the small intestine, causing intestinal ischemia.There are several possibilities that can cause stent dislodgement including but not limited to an incorrectly sized sheath for the product, overuse of the sheath during the procedure causing failure of the hemostatic valve and a hemostatic valve that is too tight or was not placed with the obturator that was provided.The instructions for use states "do not force passage or withdrawal of the guidewire or delivery system if resistance is encountered.".

• 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: 6253070
• MDR Text Key: 64921459
• Report Number: 1219977-2017-00005
• Device Sequence Number: 1
• Product Code: JCT
• UDI-Device Identifier: 00650862854121
• UDI-Public: 00650862854121
• 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: 01/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2017
• 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: 85412
• Device Catalogue Number: 85412
• Device Lot Number: 224667
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/26/2015
• 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
• Treatment: 6FR CORDIS SHEATH
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Weight: 93