MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC; PLATE,FIXATION,BONE

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

Patient Problems Erosion (1750); Fistula (1862); Hematoma (1884); Hemoptysis (1887); Blood Loss (2597)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown plate/unknown lot.Part and lot numbers are unknown; udi number is unknown.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).

Event Description

This report is being filed after the review of the following journal article: bavare, charudatta et al (2011), delayed aortic rupture after aortic endograft placement in patient with spinal hardware, the annals of thoracic surgery, volume 92, issue 4, october 2011, pages 1512-1514 (usa).The purpose of this study describe a patient who underwent open and endovascular repair of an aortic injury due to spinal hardware, with erosion of the spinal hardware through the descending thoracic aorta between the spinal hardware and the endovascular stent graft.A 45-year-old woman presented with a large calcified thoracic disc herniation at t7 to t8 with severe spinal cord compression and myelopathy.She underwent a left transthoracic t7 corpectomy, partial t8 corpectomy, and excision of the calcified disk herniation followed by reconstruction with a fibular strut graft and synthes thoracic lateral plate and screws.The thoracic exposure was performed by a general surgeon with experience with thoracic exposure.On postoperative day 1, an intrathoracic bleed of the left chest developed in the patient.A covering general surgeon took the patient back and evacuated large clot without exploring the aorta with a belief that it was a bleed from the chest wall.On postoperative day 2, another massive intrathoracic bleed developed in the patient now with hemorrhagic shock.At this time, the cardiovascular surgeon consulted for help with the complication.During this exploration, an aortic laceration was found and was repaired primarily with nonabsorbable sutures and a pedicled intercostal muscle flap between the aorta and the spinal hardware.Between postoperative days 60 and 80, the patient presented with mild recurrent hemoptysis, she then underwent an extensive evaluation including bronchoscopy, computed tomographic angiography, arteriography, and eventual embolization of the left inferior phrenic artery.Hemoptysis was attributed to an arteriobronchial fistula, which was controlled with arterial embolization.The patient returned again with massive hemoptysis 5 months after her index operation.She underwent a bronchoscopy, left redo-thoracotomy, and left lower lobectomy.Evacuation of a hematoma located around the aorta near the hardware exposed active bleeding from the aorta with visible erosion of the synthes plate (synthes north america) into the posteromedial aortic wall.The descending aorta was resected between the origin of the left subclavian artery and the diaphragmatic hiatus with a 26-mm dacron tube graft.The spinal hardware (synthes north america, west chester, pa) was removed.A pedicled omental flap was mobilized from the abdomen and placed over the graft.Multiple iatrogenic rib fractures from the previous thoracotomy were repaired with the matrixrib fixation system (synthes north america, west chester, pa).The chest was closed with two large bore thoracostomy tubes in place.The rest of the postoperative course was remarkably uneventful.Cultures from the hematoma were sterile.This report is for an unknown synthes thoracic lateral plate this is report 1 of 2 for (b)(4).

• Type of Device: PLATE,FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 8099939
• MDR Text Key: 128210059
• Report Number: 2939274-2018-55091
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/02/2018

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/02/2018
• Initial Date FDA Received: 11/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR