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

Model Number 00884450403440

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bradycardia (1751); Low Blood Pressure/ Hypotension (1914); Pulmonary Infarction (2021); Heart Failure/Congestive Heart Failure (4446)

Event Date 09/01/2017

Event Type  Death  

Manufacturer Narrative

The suspect device is not expected to return for evaluation.A follow up will be submitted when the evaluation is complete.

Event 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.

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®
• Type of Device: 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: 15638439
• MDR Text Key: 302068626
• Report Number: 9615728-2022-00003
• Device Sequence Number: 1
• Product Code: NAJ
• UDI-Device Identifier: 00884450403440
• UDI-Public: 00884450403440
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K021397
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 00884450403440
• Device Catalogue Number: S620GH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Sex: Female