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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Pulmonary Embolism (1498); Dyspnea (1816); Cardiac Perforation (2513)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Neither the device nor applicable imaging films were returned to manufacturer for evaluation therefore we are unable to determine the definitive cause of event.

Event Description

It was reported that patient underwent percutaneous balloon kyphoplasty on an unknown date.The pre-operative diagnosis was vertebral body compression fractures of l2 and l3.Intra-operatively, during injection, cement extravasation was visualized in the paravertebral venous plexus and as a result, the injection was stopped immediately.The patient was asymptotic after the procedure.Post-operatively, 12 days later, patient complained of sudden onset of dyspnea.A chest radiograph revealed multiple short linear radiopaque foreign bodies in the right lower lung field and a short linear and dense radiopaque foreign body over-laying the cardiac silhouette.Emergency computed tomography (ct) revealed right hydropneumothorax and foreign bodies in the right lower pulmonary arteries and the right ventricle (rv).A coronary ct angiogram disclosed a needle shaped piece of cement that had perforated the rv wall just to the right of the right coronary artery.After the diagnosis of cardiac perforation and pulmonary embolism caused by cement leakage, emergency surgery was undertaken.To prevent liver function deterioration after the operation, it was decided to remove the needle-shaped cement piece from the right ventricular wall, without cardiopulmonary bypass and cardia arrest.A 4-cm segment of hard whitish needle-shaped material was easily extracted.Two days, post-operatively, an echocardiogram revealed no remnants of the foreign body or functional disorder of the heart, and although a follow-up ct scan demonstrated foreign bodies in the right lower pulmonary arteries, there was no substantial change in the distribution of the cement.During post-surgical treatment, liver dysfunction was gradually aggravated due to cirrhosis.Treatment for liver failure continued in the intensive care unit; however, the patient died 7 months after the operation.A postmortem examination was not performed.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Type of Device: CEMENT, BONE, VERTEBROPLASTY
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 6629098
• MDR Text Key: 77224593
• Report Number: 1030489-2017-01509
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/17/2017
• Was Device Evaluated by Manufacturer?: No
• 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: 74 YR