MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR PROG VALVE INLINE W SG; CHPV WITH SG

Catalog Number 823162

Device Problem No Flow (2991)

Patient Problem Failure of Implant (1924)

Event Date 07/07/2021

Event Type  Injury  

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 a hakim valve was implanted to a patient via v-p shunt on (b)(6) 2020 with 100mm2o.The patient is a (b)(6) female patient with a primary disease of a brain tumor.The set pressure was gradually reduced to 30 and the ventricles size did not changed.The contrast medium was passing.When the physician checked the valve the pressure was high but it was not flowing,.Therefore, valve was removed on (b)(6) 2021 and replaced to strata(medtronic).The patient is in stable condition.

Event Description

N/a.

Manufacturer Narrative

The hakim valve was returned for evaluation.Device history record (dhr): the product code 823162 with lot 3334632 conformed to the specifications when released to stock.Failure analysis: the valve was visually inspected; a small cut/tear in the silicone housing on the siphon guard was noted and a scratch in the silicone housing was noted near the proximal connector, as well as needle holes in the needle chamber.The position of the cam when valve was received was 120mmh2o.The valve was hydrate.The valve was leak tested and only leaked from the needle hole in the needle chamber no leakage was noted from the cut/tear in the silicone housing over the siphon guard.The valve passed the test for programming, occlusion, reflux, siphon guard and pressure.No root cause could be determined as the technician could not confirm any problem with the valve at the time of investigation.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, at the time of investigation no functional issues were noted.The root cause for the cut/tear/scratch in the silicone housing is probably due to wrong handling, as noted in the ifu: silicone has a low cut/tear resistance.Do not use sharp instruments when handling the silicone valve or catheter, use shod forceps.Cuts or abrasions from sharp instruments may rupture or tear the silicone components.No leakage was noted from the damaged silicone housing at the time of investigation.

• Brand Name: PROG VALVE INLINE W SG
• 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: 12289053
• MDR Text Key: 265428293
• Report Number: 3013886523-2021-00356
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K041296
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 09/29/2021

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Catalogue Number: 823162
• Device Lot Number: 3334632
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2021
• Initial Date Manufacturer Received: 07/15/2021
• Initial Date FDA Received: 08/06/2021
• Supplement Dates Manufacturer Received: 09/14/2021
• Supplement Dates FDA Received: 09/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 9 YR