On (b)(6) 2020, an 8mm amplatzer septal occluder (asd) was selected for implant.During deployment, the device did not appear to sit properly.The prosthesis was recaptured and replaced with another 8mm asd device.The patient did not suffer any adverse health consequences.
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Additional information:h3, h6, h10.An event of the device not sitting properly after being implanted was reported.A more comprehensive assessment could not be performed as the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.
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