MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD MICRO CHPV UNITIZED

Model Number	82-3114
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Codes	Fatigue (1849); Vomiting (2144)
Date of Event	01/28/2022
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
A facility reported a hakim valve was implanted with setting 130mmhg on (b)(6) 2015.The valve setting changed to 80mmhg and several attempts were done to readjust it ( (b)(6)and (b)(6) 2022) without success.The patient had vomiting and marked asthenia.Revision surgery was performed on (b)(6) 2022 to replace the valve and symptoms improved.
Additional 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 or Problem Description
A facility reported a hakim valve was implanted with setting 130mmhg on (b)(6) 2015.The valve setting changed to 80mmhg and several attempts were done to readjust it ((b)(6)and (b)(6) 2022) without success.The patient had vomiting and marked asthenia.Revision surgery was performed on (b)(6) 2022 to replace the valve and symptoms improved.
Additional Manufacturer Narrative
The valve was returned for evaluation: dhr - lot ctcbgp, conformed to the specifications when released to stock.Failure analysis - the valve was visually inspected; some biological debris was noted.The valve was tested for programming: the valve failed the test, the cam mechanism did not move during the programming process.The valve was reflux tested; the valve failed the test.The valve was then pressure tested; the valve failed the test.The silicone was cut just after valve casing.The valve was retested for programming; the valve failed the test, the cam mechanism did not move during the programming process.The valve was dismantled and was examined under microscope at appropriate magnification: biological debris was found on the ruby ball, on the seat of the ruby ball, on the spring, on the spring pillar, on the cam mechanism, and on the base plate.The cam magnets were controlled; the polarization was abnormal.The valve passed he tests for occlusion, leak.The root cause for the programing issue reported by the customer could be due to common magnets greater than 80 gauss, such as house hold magnets.Loudspeaker magnets, and language lab headphone magnets, may affect the valve setting when placed close to the valve as noted in the ifu under warnings.The root cause for the reflux issue noted during the investigation was due to biological debris and protein build up found on the ruby ball, the biological debris is stopping the ball from being seated correctly.The root cause for the failed pressure test issue noted during the investigation was due to biological debris and protein build up found on the ruby ball.The root cause for the abnormal polarization was probably caused by an exposition of a too strong magnetic field, as noted in the ifu, ¿any magnet may experience a degradation of magnetic field strength as a consequence of exposure to the significantly stronger magnet field induced in a mri procedure.

• Brand Name: MICRO CHPV UNITIZED
• Common Device Name: CHPV
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 13536553
• Report Number: 3013886523-2022-00047
• Device Sequence Number: 5038453
• Product Code: JXG
• UDI-Device Identifier: 10886704041498
• UDI-Public: (01)10886704041498(17)200131(10)CTCBGP
• Combination Product (Y/N): N
• PMA/510(K) Number: K053107
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2020
• Device Model Number: 82-3114
• Device Catalogue Number: 823114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/02/2022
• Supplement Date Received by Manufacturer: 03/18/2022
• Initial Report FDA Received Date: 02/15/2022
• Supplement Report FDA Received Date: 04/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/13/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown