MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY STRATA II SHUNT ASSEMBLY, REGULAR, WITH BIOGLIDE; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number	27819
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported the patient with hydrocephalus due to an aneurysm surgery underwent a shunt implant procedure.During the operation, the ¿air tightness test¿ revealed that the valve was damaged and leaked.The valve was replaced and the patient was doing well post-operatively.The patient¿s medical history included hypertension.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information received reported that "air tightness test" referred to the patency test.It was noted that the doctor performed a leak test to reflect the leak.The patient was discharged successfully after surgery.
Additional Manufacturer Narrative
The returned valve was patent.The valve met the requirements for valve flux and pressure-flow testing.It did not meet the requirements for leak testing, siphon, reflux, and preimplantation.The valve did not meet the requirements for leak testing due to tears/cuts on the casing of the delta chamber, dome, and proximal occluder.It is unknown how or when this damage occurred.The ifu cautions, ¿improper use of instruments in the handling or implantation of shunt products may result in the cutting, slitting or crushing of components.Such damage may lead to loss of shunt integrity¿¿ proteinaceous debris was observed on the interior and exterior of the valve.The ifu cautions, ¿care must be taken to ensure that particulate contaminants are not introduced into shunt components during preimplantation testing or handling.Introduction of contaminants could result in improper performance of the shunt system.Particulate matter that enters the shunt system may result in shunt occlusion¿¿ all valves are 100% tested at the time of manufacture.If information is provided in the future, a supplemental report will be issued.

• Brand Name: STRATA II SHUNT ASSEMBLY, REGULAR, WITH BIOGLIDE
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 8210287
• Report Number: 2021898-2019-00004
• Device Sequence Number: 19246737
• Product Code: JXG
• UDI-Device Identifier: 00643169975637
• UDI-Public: 00643169975637
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K042465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: 27819
• Device Catalogue Number: 27819
• Device Lot Number: E44836
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2018
• Supplement Date Received by Manufacturer: 01/29/2019; 02/15/2019
• Initial Report FDA Received Date: 01/02/2019
• Supplement Report FDA Received Date: 01/31/2019; 03/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 70