MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR HAKIM PROGRAMMABLE VALVE; CHPV

Catalog Number XXX-HAKIM PROGRAMMABLE VALVE

Device Problem Output Problem (3005)

Patient Problem Failure of Implant (1924)

Event Date 05/25/2021

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 on (b)(6) 2012.It was stuck on setting 40 and the setting cannot be changed.The valve was removed on (b)(6) 2021 and a new shunt was implanted (certas programmable valve, ref: (b)(4)).

Manufacturer Narrative

Updated fields: d6, d9, g3, g6, h2, h3, h6, h10.Additional information received: it was reported initially that patient is a 2 year-old female; however, additional information received states that the age and gender can not be confirmed.It was confirmed the implant date was (b)(6), 2012."the device in this patient was implanted in 2012.In 2021, it shifted from its previous setting of 110 to 40.This setting was resistant to all attempts to change the setting to a higher value, and was confirmed on x-ray.In the context of the lower setting, the patient developed symptoms of low intracranial hypotension (headaches with exertion and positional).The timeframe between implantation and symptom development was 9 years.The product was explanted on the (b)(6) 2021 and a new valve inserted.The patient is now well, and their symptoms have improved.".

Event Description

N/a.

Manufacturer Narrative

Updated fields:  d4, d9, g3, g6, h2, h3, h4, h6, h10.Unique device identification (udi): (b)(4).Unique device identification (udi): (b)(4).The hakim valve was returned for evaluation.Device history record (dhr) - the product code 823164 with lot cmkb3w conformed to the specifications when released to stock.Failure analysis - the valve was visually inspected; it was noted that the cam mechanism and cam pillar were dislodged, a bump mark was noted in the valve casing, cuts/tears/scratches and needle holes were noted in the silicone housing.The position of the cam when valve was received was not possible as the cam mechanism was dislodged.The valve was hydrated.The valve could not be programed or pressure tested due to the dislodged cam mechanism.The valve was reflux tested and valve failed the test due to the dislodged cam mechanism.The valve was dismantled and was examined under microscope at appropriate magnification and bump marks were noted in the valve casing.The cam magnets were controlled and magnets passed.The valve was leak tested and no leaks noted.The valve passed the test for occlusion.The root cause for ¿stuck on 40.Can¿t change setting¿ as reported by the customer is due to the dislodged cam mechanism and cam mechanism pillar.The root cause for the dislodged cam mechanism and cam mechanism pillar is due to the valve receiving a hard knock.The root cause for the bump marks in the valve casing is due to the valve receiving a hard knock.The root cause for the cut/tear/scratches in the silicone housing and the marks in the valve casing noted during the investigation, 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.

Event Description

N/a.

• Brand Name: HAKIM PROGRAMMABLE VALVE
• Type of Device: CHPV
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• MDR Report Key: 11984274
• MDR Text Key: 255746309
• Report Number: 3013886523-2021-00267
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 09/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2016
• Device Catalogue Number: XXX-HAKIM PROGRAMMABLE VALVE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2021
• Date Manufacturer Received: 09/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 2 YR