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

Model Number 428

Device Problem Positioning Failure (1158)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/19/2021

Event Type  malfunction  

Event Description

As per the report from the (b)(4) distributor while deployment stent slipped over the balloon.Further clarification provided - physician was able to pass it through the tunneling device into the sheath but then while pushing it further the stent slipped off the balloon into the sheath and they had to take out the whole system and retrieve the stent and placed another cp stent.

Manufacturer Narrative

Device has not returned to numed for evaluation.If it does return and an update is needed, the information will be sent in a follow-up mdr report.The complaint stent was not returned so the root cause of the complaint cannot be positively determined, however, typically this type of complaint is from the stent catching on the hemostasis valve of the introducer.This causes the stent to be pushed back and off the balloon.The production traveler (dhr) was reviewed and no issues were found.All devices in this lot met the criteria for release and distribution.There are no other associated complaints with this lot of devices.

Manufacturer Narrative

Device was returned on 12/21/2021.The cmcp was returned to numed in its box and pouch.The stent and balloon are bloody.The stent is on the balloon.The stent moves easily on the balloon until the center of the stent reaches the shoulder areas of the balloon.The stent would not enter a 14fr ook check-flo introducer without moving.The od of the stent was measured at the distal end, center, and proximal end.The distal was 0.215", the center was 0.179" and the proximal was 0.197".It is likely that the stent was partially expanded before the physician attempted to pass it through the introducer.The slight expansion and flaring at the ends of the stent are consistent with a partial inflation of the inner balloon during preparation.This complaint is attributed to user handling of the device.A comparative cmcp of the same size was tested.The stent easily passed through the cook check-flo introducer.The production traveler (dhr) was reviewed and no issues were found.All devices in this lot met the criteria for release and distribution.There are no other associated complaints with this lot of devices.

Event Description

As per the report from the foreign distributor - while deployment stent slipped over the balloon.Further clarification provided - physician was able to pass it through the tunneling device into the sheath but then while pushing it further the stent slipped off the balloon into the sheath and they had to take out the whole system and retrieve the stent and placed another cp stent.

• Brand Name: COVERED 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: 13044740
• MDR Text Key: 284476639
• Report Number: 1318694-2021-00013
• Device Sequence Number: 1
• Product Code: PNF
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P150028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/05/2022

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 Model Number: 428
• Device Catalogue Number: CMCP019
• Device Lot Number: CMCP-3332
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2021
• Initial Date FDA Received: 12/20/2021
• Supplement Dates Manufacturer Received: 11/29/2021
• Supplement Dates FDA Received: 01/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/03/2021
• 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: 20 YR
• Patient Sex: Male