MAUDE Adverse Event Report: MERIT MEDICAL, INC EMBOSPHERE®; AGENTS,EMBOLIC,FOR TREATMENT OF UTERINE FIBROIDS

Model Number	00884450403464
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bradycardia (1751); Low Blood Pressure/ Hypotension (1914); Pulmonary Infarction (2021); Heart Failure/Congestive Heart Failure (4446)
Date of Event	09/01/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
The suspect device is not expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
Event or Problem Description
The account alleges that in (b)(6) 2017, after a uterine artery embolization procedure where embolics were used, the patient died.Death caused by acute right heart failure due to pulmonary infarction during uae (uterine artery embolization) procedure.
Additional Manufacturer Narrative
The suspect medical device could not be returned for investigation.The complaint could not be confirmed.The root cause could not be determined.The implant 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.There is no evidence to suggest that any manufacturing-related concerns contributed to the adverse event.

• Brand Name: EMBOSPHERE®
• Common Device Name: AGENTS,EMBOLIC,FOR TREATMENT OF UTERINE FIBROIDS
• Manufacturer (Section D): MERIT MEDICAL, INC; bat. a- parc des nations; 383 rue de la belle etoile; roissy charles de gaulle, cedex 95958 ; FR 95958
• Manufacturer (Section G): MERIT MEDICAL, INC; bat. a- parc des nations; 383 rue de la belle etoile; roissy charles de gaulle, cedex 95958 ; FR 95958
• Manufacturer Contact: bryson heaton ; 1600 merit parkway; south jordan, UT 84095 ; 8012084662
• MDR Report Key: 15638440
• Report Number: 9615728-2022-00004
• Device Sequence Number: 20427240
• Product Code: NAJ
• UDI-Device Identifier: 00884450403464
• UDI-Public: 00884450403464
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K021397
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2022

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 Model Number: 00884450403464
• Device Catalogue Number: S820GH
• 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: 10/07/2022
• Supplement Date Received by Manufacturer: 01/03/2023
• Initial Report FDA Received Date: 10/20/2022
• Supplement Report FDA Received Date: 01/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Female