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

Catalog Number UNKNOWN-C

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

Patient Problems Pulmonary Embolism (1498); Hemorrhage/Bleeding (1888); Thromboembolism (2654)

Event Date 08/30/2013

Event Type  Injury  

Manufacturer Narrative

These events were identified during review of scientific literature.The article contained only limited and non-specific device information.Contact with the corresponding author has been unsuccessful in yielding additional device information.The event reported in the source literature could not be matched to information previously reported to medtronic neurosurgery.The products were unavailable for return.Therefore an evaluation of device performance was not possible.A review of the manufacturing records was not possible as no lot numbers were provided.All catheters are 100% inspected at the time of manufacture.Literature article: risks for hemorrhagic complications after placement of external ventricular drains with early chemical prophylaxis against venous thromboembolisms authors: omar tanweer, m.D., akwasi boah, m.D., and paul p.Huang, m.D.J neurosurg 119:1309¿1313, 2013 http://thejns.Org/doi/abs/10.3171/2013.7.Jns13313.

Event Description

Medtronic neurosurgery identified the following information upon review of scientific literature: the study included 99 patients with 111 external ventricular drain (evd) placements.According to the report, reasons for evd placement included aneurysmal subarachnoid hemorrhage, hypertensive thalamic and intraventricular hemorrhage, traumatic brain injury, and other (for example, stroke, tumor, vascular malformations, infections).Group analysis showed a trend toward differences in drain-related hemorrhages based on diagnosis at time of admission, but statistical significance was not reached.In the study, chemical prophylaxis was started later for patients with nonlesional intracerebral hemorrhages and earlier for patients with nonhemorrhagic etiologies.Reportedly, direct comparison between the two groups failed to show a significant difference in the incidence of any new hemorrhage after placement of a ventricular drain.There were also no significant differences in the rates of radiographically significant hemorrhages.Per the article, in the early prophylaxis group, 3 venous thromboembolisms (vtes) (deep vein thromboses) were discovered in 32 patients screened for clinically suspected vtes.In the delayed prophylaxis group, 5 vtes (3 deep vein thromboses and 2 pulmonary embolisms) were discovered in 33 screened for clinically suspected vtes.

Manufacturer Narrative

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

• Brand Name: UNKNOWN CATHETER
• 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: bob shokoohi ; 125 cremona drive; goleta, CA 93117 ; 8055718725
• MDR Report Key: 6031188
• MDR Text Key: 57490556
• Report Number: 2021898-2016-00374
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/16/2016

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: No Information
• Device Catalogue Number: UNKNOWN-C
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/16/2016
• Initial Date FDA Received: 10/14/2016
• Supplement Dates Manufacturer Received: 09/16/2016
• Supplement Dates FDA Received: 09/26/2017
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 49 YR