MAUDE Adverse Event Report: MERIT MEDICAL SYSTEM IRELAND STABILIT; CEMENT, BONE, VERTEBROPLASTY

Model Number	00884450441459
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Extravasation (1842)
Date of Event	04/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
Event or Problem Description
The account alleges that during a balloon kyphoplasty procedure, performed on a female patient within the interventional surgical suite, the implant cement migrated via extravasation to the patient's thoracic cavity.The patient experienced ventricular tachycardia and arrhythmia and condition destabilized.The physician was able to surgically remove the cement from the thoracic cavity and heart.Patient is stable and recovering.
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.The physician involved in the case indicated that this adverse event was not due to any issue with the bone cement or delivery instruments, but likely due to the patient's anatomy.No device failure to report.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.
Event or Problem Description
No device failure product problem or malfunction to report.

• Brand Name: STABILIT
• Common Device Name: CEMENT, BONE, VERTEBROPLASTY
• Manufacturer (Section D): MERIT MEDICAL SYSTEM IRELAND; parkmore business park west; ballybrit, galway ; EI
• MDR Report Key: 11742160
• Report Number: 9616662-2021-00010
• Device Sequence Number: 3984737
• Product Code: NDN
• UDI-Device Identifier: 00884450441459
• UDI-Public: 00884450441459
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K072496
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2021
• Device Model Number: 00884450441459
• Device Catalogue Number: MX-1100L-01/C
• Device Lot Number: K1918174
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/12/2021
• Supplement Date Received by Manufacturer: 05/10/2021
• Initial Report FDA Received Date: 04/28/2021
• Supplement Report FDA Received Date: 05/12/2021
• 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: Hospitalization; Life Threatening; Required Intervention