MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION I-CAST COVERED STENT; PROSTHESIS, TRACHEAL, EXPANDABLE

Model Number 85416

Device Problems Deflation Problem (1149); Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/05/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that while stenting an anastomosis between vessels the balloon was not fully deflated.When clinician attempted to pull the delivery catheter out the balloon then snapped off and was dislocated from the shaft.

Manufacturer Narrative

A review of the case details and of the returned product were reviewed to determine the cause of the compliant.The case details provided indicate that the icast covered stent was delivered inside a previously deployed stent at the location of the cephalic arch.The details do not provide how long this stent had been in place before this intervention.The previously deployed stent was noted to be "nearly occluded".The icast covered stent was deployed inside the previously deployed stent at a pressure of 10 to 11 atm.Upon deflation and withdrawal the details state the balloon ¿got impacted in the middle of the av fistula but remained over the wire.Numerous attempts were made to retrieve the balloon with a snare but were unsuccessful.The patient was taken to the operating room where we threw a cut down at the elbow".The described case as reported stated the following: "while stenting an anastomosis between the vessels the balloon was not fully deflated and pulled back and then snapped off and balloon was dislocated from the shaft".This is important as if the balloon was not allowed sufficient time to deflate, upon withdrawal the balloon could catch on the previously deployed stent or even prevent the balloon from entering the introducer sheath.The instructions for use in the deployment of the icast covered stent section specifies the following in regards to balloon deflation step 5.Deflate balloon by pulling vacuum on the inflation device to its maximum volume for 40 seconds.Verify full balloon deflation via fluoroscopy before proceeding to step 6.Step 6.Very slowly withdraw the balloon from the icast covered stent, maintaining negative pressure.The returned product consisted of the destroyed balloon.Based on the condition of the balloon an assessment of the integrity of the balloon could not be conducted.There was a large tear in the balloon that may have occurred at the time of the attempted removal with the snare.The balloon appeared to have necked down to a smaller diameter prior to breaking at the proximal balloon weld.A review of the relevant data within the device history records was also reviewed.Per the product user requirements the proximal balloon bond must not break at a force below 15n.For the proximal balloon bond to break during withdrawal a force greater than 15n must have been applied while attempting to pull the balloon back through the introducer sheath.A review of the proximal balloon bond tensile force data collected during the quality performance testing that every lot of catheters manufactured is subjected to was reviewed to ensure the minimum specification for proximal bond tensile force was met.The review shows that 20 units were proximal balloon bond tensile tested from this catheter lot and the minimum tensile break force recorded was 25.5n.The minimum allowable break tensile force is 15 n.The minimum break force seen from this production lot exceeds this requirement by over 10n.A review of the balloon burst pressure was also reviewed.The test results from the quality performance testing of 20 samples burst tested shows that the minimum burst pressure was 21.1 atm.This is well above the rated burst pressure of 12atm as indicated on the product label.A review of the proximal and distal skive dimensions found within the device history records shows that all product dimensional requirements met specifications.Based on the details of the complaint and the condition of the returned balloon the investigation cannot confirm that the reported event was the fault of the icast stent device.The cause of the complaint is most likely that the balloon was not deflated fully prior to attempting to pull the deflated balloon back thorough the introducer sheath as the details indicate.

Event Description

N/a.

• Brand Name: I-CAST COVERED STENT
• Type of Device: PROSTHESIS, TRACHEAL, EXPANDABLE
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 10394339
• MDR Text Key: 203342462
• Report Number: 3011175548-2020-01017
• Device Sequence Number: 1
• Product Code: JCT
• UDI-Device Identifier: 00650862854169
• UDI-Public: 00650862854169
• 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
• Report Date: 08/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2022
• Device Model Number: 85416
• Device Catalogue Number: 85416
• Device Lot Number: 446057
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2020
• Date Manufacturer Received: 11/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: KUMPE CATHETER
• Patient Age: 80 YR