MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY UNKNOWN DELTA VALVE/SHUNT; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number UNKNOWN-A

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

Patient Problems Hematoma (1884); Paresis (1998); Confusion/ Disorientation (2553)

Event Type  Injury  

Manufacturer Narrative

Please note that this age is the average age of the patients reported in the article, as the actual age of patients involved is noted in each event as known.This event was identified during review of scientific literature.The article contained only limited and non-specific device information.The event reported in the source literature could not be matched to information previously reported to medtronic neurosurgery.

Event Description

Peter birkeland, jens lauritsen, frantz rom poulsen.Subdural haematoma complicating shunting for normal pressure hydrocephalus in the setting of concomitant antiplatelet medication-a report of 11 cases.British journal of neurosurgery.Doi: 10.3109/02688697.2016.1173196 abstract: objective: to report on the occurrence and management of subdural haematoma after shunt implantation for normal pressure hydrocephalus and to determine the risk of recurrence in the setting of antiplatelet medication.Methods: from a consecutive series of 80 patients implanted with a cerebrospinal fluid shunt for normal pressure hydrocephalus, records from 11 patients taking antiplatelet drugs, who subsequently had surgery for subdural haematoma were extracted and retrospectively reviewed.Results: patients were followed up for a mean of 1819 days after shunt implantation.Subdural haematomas occurred at a median of 335 days after shunt implantation ¿ four ipsilateral, five contralateral and two bilateral with respect to the ventricular catheter.Three patients had reoperations done within a week without having resumed antiplatelet medication in the interim.One of them had three further reoperations done before the subdural collection disappeared.Only one patient had a late recurrence almost 11 years after shunt implantation.Conclusions: subdural haematoma in the setting of a ventriculoperitoneal implantation for normal pressure hydrocephalus and concomitant antiplatelet medication can be managed along usual lines.Antiplatelet medication can be recommenced in due course with a low risk of recurrence.Reported events: one (b)(6) year old male experienced a subdural haematoma 1723 days after shunt implantation where subdural collections were located as ipsilateral.This patient was re-operated 8 days after the initial clot evaluation due to clinical deterioration.It was also stated he had a late recurrence of bilateral subdural collections almost 11 years after the shunt implantation, which were treated by valve replacement surgery.The patient had his antiplatelet medication discontinued at the time of the first subdural haematoma.Indication for antiplatelets was transitory ischaemic attack (tia).One (b)(6) year old male experienced a subdural haematoma 576 days after shunt implantation where subdural collections were located as contralateral.It is unclear whether the patient was treated with burr hole drainage, evacuated through a craniotomy, or valve replacement to a programmable valve.One (b)(6) year old female experienced a subdural haematoma 101 days after shunt implantation where subdural collections were located as bilateral.This patient was diagnosed with normal pressure hydrocephalus (nph).She had previously suffered a myocardial infarction and was on 75 mg aspirin daily as a secondary prophylaxis.Aspirin was withheld from 10 days prior to shunt implantation surgery until 2 days postoperatively.Approximately 3 months later, she was referred back with confusion.A ct scan showed bilateral chronic subdural haematomas.At surgery, the subdural haematomas were evacuated through bilateral burr holes.Her valve was replaced for another manufacturer's valve and was set at 8.Aspirin was not given until an interval scan at 4 weeks showed resolution of the subdural collections and expansion of the brain.The setting of the replacement valve was gradually decreased to 3, and she made a good recovery.One (b)(6) year old male experienced a subdural haematoma 91 days after shunt implantation where subdural collections were located as contralateral.It is unclear whether the patient was treated with burr hole drainage, evacuated through a craniotomy, or valve replacement to a programmable valve.Indication for antiplatelets was abdominal aortic aneurysm (aaa).One (b)(6) year old male experienced a subdural haematoma 1688 days after shunt implantation where subdural collections were located as bilateral.It is unclear whether the patient was treated with burr hole drainage, evacuated through a craniotomy, or valve replacement to a programmable valve.Indication for antiplatelets was ischaemic heart disease (ihd).One (b)(6) year old male experienced a subdural haematoma 109 days after shunt implantation where subdural collections were located as contralateral.This patient developed normal pressure hydrocephalus (nph) secondary to an aneurysmal subarachnoid haemorrhage.Subsequently after implantation, he suffered a non-st-elevation myocardial infarction (nstemi) and had a drug-eluding cardiac stent inserted in the circumflex branch of the left coronary artery.He was prescribed lifelong aspirin 75 mg daily and ticagrelor 90 mg for 12 months.Approximately 3 months after shunt implantation, he was readmitted with confusion anda hemiparesis.A ct head showed a large acute in chronic subdural haematoma with midline shift.Antiplatelet medication was stopped and burr hole evacuation was done.Two days later, he deteriorated again to confusion, and a redo evacuation was done through the same burr hole under platelet cover.The valve was replaced to another manufacturer's valve and set at 8.After discussion with his cardiologist, aspirin was recommenced 8 days later to protect the cardiac stent from clotting; however, we found that it would be associated with an unacceptable high risk to start the patient on ticagrelor again.Guided by serial ct scans the setting of the valve was gradually decreased to a final setting at 3 two months later.The scans showed successively regression and finally resolution of the subdural collection.In the interim, it was at times difficult to distinguish between symptoms caused by the subdural collection or by normal pressure hydrocephalus.He eventually recovered to being able to carry out most usual activities.

• Brand Name: UNKNOWN DELTA VALVE/SHUNT
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• Manufacturer (Section G): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• Manufacturer Contact: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 6966794
• MDR Text Key: 89921387
• Report Number: 2021898-2017-00531
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: DA
• 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
• Report Date: 10/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN-A
• Device Catalogue Number: UNKNOWN-A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/25/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 71 YR