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

Model Number MSB_UNK_BKP_CEMENT

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

Patient Problems Fever (1858); Pain (1994); Chills (2191); Pseudoaneurysm (2605); Thrombosis/Thrombus (4440)

Event Date 07/23/2022

Event Type  Injury  

Event Description

Summary: paravertebral pseudoaneurysms are infrequent following vertebral augmentation but can be difficult to manage due to their p roximity to the arterial supply of the spinal cord.Here, there are two distinct manifestations of this complication with associated anatomy and management.In the first, a pseudoaneurysm developed following radiofrequency ablation and kyphoplasty at the l2 and l4 levels.Direct puncture embolization initially failed to close the pseudoaneurysm, but stasis was ultimately achieved via trans-art erial embolization.In the second, vertebral augmentation at the t9 and t11-l3 levels was complicated by formation of a pseudoaneurysm fed by a segmental artery and a long paravertebral anastomotic vein.Due to the patient's poor medical status, intervention was not performed.Understanding vertebral arterial anatomy is crucial for preventing and treating vascular injury in vertebral augmentation.Reported events: a 62-year-old man with end-stage renal disease on hemodialysis, traumatic brain injury with seizure disorder, schizophrenia, and mul tiple myeloma was admitted for back pain and difficulty ambulating following a mechanical fall.Imaging demonstrated acute compression fractures of the l2 and l4 vertebrae.Conservative management was attempted but, given persistent pain limiting mobility, he ultimately underwent vertebral augmentation with radiofrequency ablation (rfa) of the l2 and l4 vertebral bodies, which displayed increa sed marrow heterogeneity on mri concerning for multiple myeloma progression or recurrence.On hospital day 6, bilateral transpedicular access was obtained at the l2 level with 10-gauge kyphon express ii osteo introducers (medtronic), after which rfa was performed for 15 min using 20 mm probes from the osteocool rf ablation system (medtronic).Next, fracture reduction was performed using 15 mm inflatable bone tamps (medtronic) and xpede bone cement (medtronic) was instilled.This was repeated at the l4 level.No immediate complications were encountered.The patient's pain improved, and he was discharged on hospital day 11.One month later, the patient was re-admitted for 24 h of fever, chills, and mild back pain; motor and sensory function remained intact.A ct abdomen/pelvis obtained to identify the infectious source revealed a 2.6 cm hyper-dense focus adjacent to the right l4 transverse process, which was confirmed on duplex sonography to represent a pseudoaneurysm.Given that the patient was symptomatic as well as concern for possible rupture, embolization was performed.On the morning of hospital day 8, the patient underwent hemodialysis with nephrology.After digital subtraction angiography demonstrated absence of communication with arteries supplying the spinal cord embolization was performed using three 10 mm × 14 cm nester coils.Post-embolization imaging confirmed absence of flow.On hospital day 10, the patient again underwent hemodialysis.He was then sent to the angiography suite, where a 6 french sheath was introduced into the right common femoral artery and a 5 french mickelson catheter (cook medical) was used to sequentially select the right l2¿4 vertebral arteries.The pseudoaneurysm was found to be supplied by the l3 artery, so a 2.8 french progreat microcatheter was advanced into the vessel and embolization performed to stasis using gelfoam slurry.An ultrasound confirmed complete thrombosis.On hospital day 12, he was discharged on 5 weeks of daily ciprofloxacin 500 mg once daily for presumed mycotic aneurysm, as recommended by the infectious disease team.An 88-year-old female with osteoporosis complicated by multilevel vertebral compression fractures, coronary artery disease, peripheral artery disease, paroxysmal atrial fibrillation on aspirin, dementia and arterially enhancing lesion in the right aspect of the t12 vertebral body.Five months prior to presentation, she had undergone vertebral augmentation at the t9 and t11-l3 levels.Five days prior to transfer, she presented after a syncopal event and was found to have a urinary tract infection.A ct angiogram was also obtained demonstrating a 2.3 cm esion in the aforementioned location which was thought to represent a pseudoaneurysm.Given the patient's poor medical status and absence of symptomatology attributable to the lesion, intervention was not performed.The patient began to endorse back pain while seated which was ultimately attributed to a subacute compression fracture at t8, for which the patient underwent kyphoplasty via a left parapedicular approach on hospital day 22.The patient's pain improved, and she was discharged on hospital day 29.

Manufacturer Narrative

David nam, michele h.Johnson, hamid mojibian, ryan m.Hebert, joshua cornman-homonoff " development of paravertebral pseudoaneurysms following vertebral augmentation: a report of two cases" clinical imaging 90 (2022) 39¿43.Https://doi.Org/10.1016/j.Clinimag.2022.07.004.Please note that this date is published date online.Product identifiers are unknown.Product identifier is unknown, hence 510k# is not available.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.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.

Manufacturer Narrative

Review of this mdr and/or additional information received shows that there is no information to reasonably suggest that the device in this report may have caused or contributed to a death or serious injury or that the device in this report has malfunctioned.Therefore, this event did not and does not meet the reporting requirements stipulated in 21 cfr 803.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.

• 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: 16081053
• MDR Text Key: 306501850
• Report Number: 1030489-2022-01145
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 01/03/2023
• 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: 62 YR
• Patient Sex: Male