MAUDE Adverse Event Report: NUMED, INC. MOUNTED CP STENT; AORTIC STENT

Model Number 426

Device Problem Material Rupture (1546)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/20/2019

Event Type  malfunction  

Manufacturer Narrative

This device was reported to numed on a post market clinical follow-up form.The procedure was still considered a success by the physician.The device was not returned to numed.The problem reported was that the outer balloon burst during the procedure due to a zig not completely dilated, however, the stent was able to be placed with no issues.The device was being used for an off-label indication.This device is only approved for coarctation of the aorta, and it was reported as being used for the rvot in conjunction with implantation of an endovascular pulmonary valve ((b)(6) edwards).Numed could not confirm the complaint since the device was not returned for evaluation.It is unknown as to what pressure the outer balloon was taken to and what pressure the balloon burst at.It was also noted that the physician re-crimped the stent himself before use.A comparative device was pulled and tested.The comparative device was a model variant.It was a covered and mounted cp 10zig5.5 mounted on a 26 x 6 balloon.This would be the same size balloon diameter as the complaint catheter but with a covered stent mounted on it instead of a bare stent.The stent/catheter was inflated to the labeled rbp of 3 atm with no issues.The balloon was then partially deflated, the stent removed, and one of the zigs was manually bent inwards (b)(4) to simulate what the physician thought may have been the issue with the device.The stent was them crimped down on the partially inflated balloon (b)(4).The stent/catheter combination was then inserted into a latex sleeve (b)(4) and inflated until the balloon failed.The balloon burst longitudinally at 8 atm.All numed catheters are leak tested at rbp during final inspection.A vacuum check is also performed on every bib catheter after the stent has been mounted on it to further ensure balloon integrity.(b)(4).

Event Description

As per the report from the distributor / physician - "balloon rupture due to a zig not completely dilated.".

• Brand Name: MOUNTED CP STENT
• Type of Device: AORTIC STENT
• Manufacturer (Section D): NUMED, INC.; 2880 main street; hopkinton NY 12965
• Manufacturer (Section G): NUMED, INC.; 2880 main street; hopkinton NY 12965
• Manufacturer Contact: nichelle laflesh ; 2880 main street; hopkinton, NY 12965 ; 3153284491
• MDR Report Key: 8781333
• MDR Text Key: 167996280
• Report Number: 1318694-2019-00014
• Device Sequence Number: 1
• Product Code: PNF
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P150028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 03/31/2024
• Device Model Number: 426
• Device Catalogue Number: MCP048
• Device Lot Number: MCP-0985
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/14/2019
• Initial Date FDA Received: 07/11/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2019
• 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: 62 YR