MAUDE Adverse Event Report: MICROVENTION, INC. HYDROPEARL; VASCULAR EMBOLIZATION DEVICE

Model Number	8HP2S200
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Anaphylactic Shock (1703); Low Blood Pressure/ Hypotension (1914)
Date of Event	01/22/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A search for non-conformances associated with this part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The hydropearl was implanted; therefore, a device analysis could not be performed.The root cause cannot be determined.
Event or Problem Description
It was reported that chemoembolization treatment was performed on a vessel in the liver.Prior to delivery of the lifepearl device, angiograms with contrast media were taken without any problems.After reaching the target vessel, the lifepearl loaded with 50 mg doxorubicin was mixed with 8 ml nacl and 8 ml contrast media.Immediately after beginning the slow injection, the patient felt warm and had a "warm head." a cool compress was put on the patient's head and a small amount of the lifepearl was injected.The patient began to move and "get nervous." hydropearl was then injected to ensure the embolization was completed.At this time, the patient's blood pressure and respiration rate dropped rapidly and he became unconscious.Solu decortin and iv adrenalin were administered to stabilize the patient.After preparation for intubation and cardiac resuscitation, the patient slowly began to recover.No resuscitation was required.There was no reported issue with the preparation or delivery of the hydropearl.

• Brand Name: HYDROPEARL
• Common Device Name: VASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo, ca
• MDR Report Key: 9742509
• Report Number: 2032493-2020-00046
• Device Sequence Number: 11383450
• Product Code: KRD
• UDI-Device Identifier: 00812636020624
• UDI-Public: (01)00812636020624(11)170307(17)200229(10)17030729
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K192684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/24/2020

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: Other
• Device Expiration Date: 02/29/2020
• Device Model Number: 8HP2S200
• Device Catalogue Number: 8HP2S200
• Device Lot Number: 17030729
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2020
• Initial Report FDA Received Date: 02/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention