Manufacturing review: the device history record review could not be performed as the lot number is unknown.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Approximately two months post filter deployment, it was reported, probable recurrence of pulmonary embolism.There was a possibility that the patient might have developed a pulmonary embolism.There were no device deficiencies identified within the medical records.Therefore, the investigation is inconclusive for the pulmonary embolism post deployment as no objective evidence has been provided to confirm any alleged deficiency with the filter.Based upon the available information, the definitive root cause is unknown.Labeling review:a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, and unit label) showed that the product labeling is adequate.
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