MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. MICRO PLUG SET; EMBOLICPLUG

Catalog Number	KA90001
Medical Device Problem Codes	Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The physician alleges that a preemie patient diagnosed with a patent ductus arteriosus (pda) underwent a [off-label use] pda closure procedure on (b)(6) 2022.A 5mm closure device was initially placed but had not been fully deployed because the 5mm device was causing left pulmonary artery [lpa] narrowing.The 5mm device was exchanged for a 4mm closure device that was successfully deployed within the patient.The follow-up echo studies looked good initially and then 48 hours after the procedure no residual shunt, arch obstruction, or lpa obstruction was noted.During a follow-up appointment post-pda closure procedure, a narrowing within the patient's arch had been identified.After observing the patient for a few months, the decision was made to surgically remove the device due to an aortic arch gradiant, in (b)(6) 2023.Surgical removal was successful, and 16 months post initial pda closure the patient is doing well.
Additional Manufacturer Narrative
The suspect medical device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.The device history record was reviewed, and no exception documents were found.A search of the complaint database was performed and no similar complaints for this lot number were identified.Should the device be returned later, the investigation will be reopened.

• Brand Name: MICRO PLUG SET
• Common Device Name: EMBOLICPLUG
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit pkwy; south jordan, ut 84095 ; EI 84095
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS INC.; 1600 merit pkwy; south jordan, ut 84095 ; EI 84095
• Manufacturer Contact: bryson heaton ; 1600 merit pkwy; south jordan, UT 84095 ; 8012531600
• MDR Report Key: 18895021
• Report Number: 1721504-2024-00014
• Device Sequence Number: 7458855
• Product Code: KRD
• UDI-Device Identifier: 00867966000112
• UDI-Public: 867966000112
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K182944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/01/2023
• Device Catalogue Number: KA90001
• Device Lot Number: 202882
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2024
• Initial Report FDA Received Date: 03/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/29/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 16 DA
• Patient Sex: Prefer Not To Disclose
• Patient Weight: 1 KG