MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC UNKNOWN; CEMENT, BONE, VERTEBROPLASTY

Model Number MSB_UNK_BKP_CEMENT

Device Problem Leak/Splash (1354)

Patient Problems Arrhythmia (1721); Extravasation (1842); Embolism/Embolus (4438)

Event Date 06/13/2023

Event Type  Injury  

Manufacturer Narrative

Emmanuel m.Kanoupakis, anthoula plevritaki, emmanuel p.Koutalas, george l.Lazopoulos, alexandros p.Patrianakos, mmanuel foukarakis, dimitris lempidakis, paris dimitrios kalogerakos, dimitrios koutentakis & george e.Kochiadakis.Injecting a ventricular tachycardia into the heart¿ unique case report.,j cardiovasc electrophysiol, 2023;34:1768-1771, doi:10.1111/jce.15982 b3.Please note that this date is based off of the date of acceptance of article as the event dates were not provided in the published article.D1, d4, g4: product identifiers are unknown.G2.Country: greece h3.Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.Digital sharing of the article would be in violation of copyright permission.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Summary: percutaneous balloon kyphoplasty (kp) is a minimally invasive technique performed for painful osteoporotic or neoplastic vertebral compression fractures, refractory to maximum applied conservative measures.A case was reported where 52-year-old woman was presented with a complex ventricular arrhythmia in an intraoperative context, during kyphoplasty for an osteoporotic fracture of a lumbar vertebra.An intracardiac cement embolism was diagnosed and, finally, the patient underwent an open-heart surgery with successful removal of the cardiac cement.¿o new arrhythmia was recorded during follow up.Reported events: patient was initially hospitalized in the neurosurgery department, when recurrent episodes of polymorphic non-sustained ventricular tachycardia (nsvt) were recorded in an intraoperative context.The patient was referred for balloon kyphoplasty (kp), due to a recent fracture of an osteoporotic lumbar vertebra that was refractory to conventional analgesics.Patient's preoperative examination was unremarkable, except for back pain.The procedure was completed uneventfully, and the patient was transferred to the cardiology department for further evaluation.A tra nsthoracic echocardiogram (tte) performed during a first evaluation basis, demonstrated a normal sized left ventricle (left ventricular end-diastolic diameter, lvedd = 52 mm) with a normal ejection fraction of 55%.A subsequent 24-h ambulatory electrocardiogram (ecg) revealed intermittent ventricular arrhythmias (single premature ventricular contractions 688/24 h, nsvt, 22 episodes/24 h).The patient was devoid of cardiovascular disease and denied any episodes of chest pain, dizziness, palpitations, or syncope in the past.0.The patient's clinical presentation raised suspicion of an inherited cardiomyopathy, due to her family history of dcm and the documented vts.A coronary angiography was conducted.Fluoroscopy imaging depicted a mobile radiopaque material, projected upon the cardiac silhouette, moving simultaneously with the cardiac contractions, postulating an intracardiac position.Transthoracic heart ultrasound demonstrated a presence of a foreign body(cement) inside the right ventricle.As cement material had been injected into the vertebra during the operation to stabilize the fracture, the possibility of entrapped and solidified intravenous cement leak inside the cardiac cavities should be excluded.The patient underwent a dedicated tte focusing on the right ventricle (rv), demonstrating a linear structure constituting of two parts, that were parallel to the elongated axis of the rv and rebounded at the inferior basal segment of the latter and the free ends were directing towards the rv free wall.A chest computed tomography was also performed that confirmed the above findings and also excluded coronary heart disease.Anticoagulation was initiated and the patient underwent an open heart surgery, with successful removal of the foreign body, confirming that the material was composed of cement related to recent spinal procedure.The successful surgical removal of the cement material, led to the termination of the patient's arrhythmias.Cement was extracted into two separated parts with length of 57 and 52mm each.The patient recovered from the spinal cord procedure uneventfully and regained full mobility.Serial ttes and ambulatory ecgs reported normal finding during follow-up.

• Brand Name: UNKNOWN
• Type of Device: CEMENT, BONE, VERTEBROPLASTY
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 18190128
• MDR Text Key: 328738959
• Report Number: 1030489-2023-00795
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: GR
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MSB_UNK_BKP_CEMENT
• Device Catalogue Number: MSB_UNK_BKP_CEMENT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/26/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR
• Patient Sex: Female