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

Model Number UNKNOWN-S

Device Problems Disconnection (1171); Loose or Intermittent Connection (1371); Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191); Migration (4003)

Patient Problems Hematoma (1884); Hemorrhage, Subdural (1894); Unspecified Infection (1930); Complaint, Ill-Defined (2331)

Event Date 09/26/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Tsung-hsi yang, cheng-siu chang, wen-wei sung and jung-tung liu.Lumboperitoneal shunt: a new modified surgical technique and a comparison of the complications with ventriculoperitoneal shunt in a single center.Medicina 55 (2019).Doi:10.3390/medicina55100643.Abstract: background and objectives: hydrocephalus remains a disease requiring surgical treatment even in the modern era.Ventriculo peritoneal (vp) shunt placement is the most common treatment, whereas lumboperitoneal (lp) shunts are less commonly used due to initial reports of very high rates of complications.In the present study, we retrospectively reviewed our experience of the new two-stage procedure with lp shunt implantation to assess the complications and the results of this procedure versus vp shunt insertion.Materials and methods: all patients from a single center who had received lp shunts using a medtronic strata device or vp shunts in the past six-year interval were retrospectively reviewed.The lp shunt insertion was a new two-stage procedure.We compared the three major complications and shunt revisions between the two groups, including shunt malfunction, infection, and subdural hematoma.Results: after matching the age and sex of both groups, we included 96 surgery numbers of lp shunts and 192 surgery numbers of vp shunts for comparison.In the lp shunt group, one patient (1.0%) underwent revision of the shunt due to shunt infection.In the vp shunt group, 26 surgeries (13.5%) needed revision, and 11 surgeries (5.7%) had shunt infection.Shunt malfunction occurred in 14 patients (7.3%) and all needed revisions.The revision rate showed statistically significant dierences between the lp and vp shunt groups (p <(><<)> 0.001).Conclusions: the recent improvements in the quality of the lp shunt device and the proficiency of the procedure has made the lp shunt a safer procedure than the vp shunt.The programmable valve can avoid overdrainage complications and reduce the revision rate.With our procedural steps, the lp shunt can be used to decrease the complications and revision rates.Reported events.- in the lp shunt group, one patient (1.0%) underwent revision of the lp shunt due to shunt infection.One patient (1.0%) experienced chronic subdural hematoma and subdural effusion due to overshunting after adjustment of the valve to a lower pressure.In this case, the symptoms were improved by adjusting the strata valve to a higher pressure, and a second operation was not necessary.- in the vp shunt group, 26 surgeries (13.5%) needed revision.Of these, 11 (5.7%) surgeries had shunt infection (7 patients need revisions once and 2 patients underwent two revisions).Shunt malfunction which included obstruction, disconnection, dislocation, and migration, occurred in 14 patients (7.3%) and all needed revisions.Subdural hematoma occured in 5 patients (2.6%) and one patient needed revision.

• Brand Name: UNKNOWN STRATA 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: katcha taylor ; 9775 toledo way; irvine, CA 92618 ; 7635263305
• MDR Report Key: 9298119
• MDR Text Key: 167366483
• Report Number: 2021898-2019-00402
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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: 11/08/2019

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?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN-S
• Device Catalogue Number: UNKNOWN-S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/06/2019
• Initial Date FDA Received: 11/08/2019
• 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): Hospitalization; Required Intervention