MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR SPECIAL DEVICE UNITIZED PROGRA; CHPV WITH SG

Catalog Number NS9008

Device Problem Output Problem (3005)

Patient Problem Death (1802)

Event Type  Death  

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A physician reported the catheter of a hakim programmable valve was torn.The valve was implanted via lumbar peritoneal shunt between the years, 2014-2016 for idiopathic normal pressure hydrocephalus.The valve was used with the silascon lumbar catheter (manufactured by kaneka, product code: 702-jj).The initial setting was unknown.On an unknown date, the patient¿s clinical hydrocephalus symptoms appeared to be worse.The physician attempted to change the shunt setting to low by vpv (valve positioning verification) without success.The provider attempted to change the setting under fluoroscopy, it still could not be, shunt contrast was performed.The lumbar catheter was torn (noted on x-ray).The physician decided to follow up with the patient and follow clinical symptoms rather than change the valve.Per report, the patient died due to other disease.

Event Description

N/a.

Manufacturer Narrative

Unique device identifier (udi): (b)(4).The valve was not returned for evaluation and no lot number information has been provided; therefore, an evaluation of the device could not be performed, and manufacturing records could not be reviewed.The root cause could be determined as the device was not returned.However, the possible root cause for the issue reported by the customer could be due to biological debris and protein build up interfering with the valve mechanism.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.Based on medical assessment conclusion: no supportive evidence exists that indicates that the shunt was causal to the death of the patient.The ifu states that devices for shunting csf may have to be changed at any time due to medical reasons or device failure.Per the ifu, the product is an adjustable valve, and pressure setting should be accounted for and verified when evaluating patients and establishing/executing a treatment plan.

• Brand Name: SPECIAL DEVICE UNITIZED PROGRA
• Type of Device: CHPV WITH SG
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• MDR Report Key: 10847996
• MDR Text Key: 216553445
• Report Number: 3013886523-2020-00201
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 10/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: NS9008
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death