MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION SUPERION INDIRECT DECOMPRESSION SYSTEM; PROSTHESIS, SPINOUS PROCESS SPACER/PLATE

Model Number 101-9814

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

Patient Problems Pulmonary Embolism (1498); Thrombosis/Thrombus (4440)

Event Date 03/12/2021

Event Type  Injury  

Manufacturer Narrative

Additional suspect medical device component involved in the event: product family: upn: 101-9814, model: 101-9814, serial: n/a, lot: 800315.

Event Description

It was reported that approximately a month after a spacer implant procedure, the patient developed deep vein thrombosis (dvt) in the right femoral vein and a severe saddle embolism in the upper and lower segments of the right pulmonary artery.The patient was hospitalized, administered anticoagulants, and had an inferior vena cava (ivc) filter placed to prevent further propagation of the clot.The patient was released from the hospital and was being followed by hematology.The patients functionality has improved remarkably.

Event Description

It was reported that approximately a month after a spacer implant procedure, the patient developed deep vein thrombosis (dvt) in the right femoral vein and a severe saddle embolism in the upper and lower segments of the right pulmonary artery.The patient was hospitalized, administered anticoagulants, and had an inferior vena cava (ivc) filter placed to prevent further propagation of the clot.The patient was released from the hospital and was being followed by hematology.The patients functionality has improved remarkably.Additional information was received that the dvt and saddle embolism were assessed as not related to the device or to the implant procedure.

Manufacturer Narrative

Additional suspect medical device component involved in the event: product family: superion implant, upn: 101-9814, model: 101-9814, serial: n/a, lot: 800315.

• Brand Name: SUPERION INDIRECT DECOMPRESSION SYSTEM
• Type of Device: PROSTHESIS, SPINOUS PROCESS SPACER/PLATE
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• MDR Report Key: 11735614
• MDR Text Key: 247705529
• Report Number: 3006630150-2021-01806
• Device Sequence Number: 1
• Product Code: NQO
• UDI-Device Identifier: 00884662000550
• UDI-Public: 00884662000550
• Combination Product (y/n): N
• PMA/PMN Number: P140004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/27/2021

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: 101-9814
• Device Catalogue Number: 101-9814
• Device Lot Number: 800256
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/02/2021
• Initial Date FDA Received: 04/27/2021
• Supplement Dates Manufacturer Received: 05/03/2021
• Supplement Dates FDA Received: 05/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 71 YR