(b)(4).Review of information as reported to lifecell.Review of the device history record for lot s11272.(b)(4).Qa investigation into lot s11272 resulted in no remarkable findings with no deviations or nonconformances revealed during processing with impact to product or patient safety.Although one similar complaint was reported against the lot, the physician did not attribute the event to the strattice.As of 12/29/2016, (b)(4) devices have been distributed.Lot s11272 met all qc release criteria.(b)(4).Based on the reported information, a relationship between the subject's right breast induration and the strattice cannot be determined by lifecell.Qa investigation resulted in no remarkable findings.Lot s11272 met all qc release criteria.This sae is being reported to both (b)(6) and the fda due to the investigator's assessment of the event relationship as certainly related to the strattice.It should be noted that the investigator has also assessed this event to be likely related to the radiotherapy.Device not returned to manufacturer.
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Subject #1 is a (b)(6) female, as part of the investigator initiated clinical study (rouanet/ protocol: isis), who underwent breast reconstruction on (b)(6) 2013 with a breast implant and strattice lot s11272-442.This is not a lifecell sponsored study.The following event was reported to lifecell by the study site contact on december 07, 2016: it was reported that subject 1 developed a periprosthetic induration (increase in fibrous tissue associated with inflammation) which was "annoying" on the right side of the irradiated prosthesis (onset date not reported).On june 7, 2016, the surgeon suggested removing the prosthesis.The patient was reported to be embarrassed by her reconstructed breast which is hard further to the radiotherapy.Both the strattice and breast implant were explanted from the right breast on (b)(6) 2016.Subject has recovered without sequelae.The investigator assessed the relationship as: possibly related to surgery, likely related to radiotherapy and certainly related to strattice.The subject's past medical history includes chemotherapy from (b)(6) 2013 and 3d radiotherapy in the right breast from (b)(6) 2014.As the manufacturer, lifecell is reporting this event due to the investigator's assessment that the serious adverse event is certainly related to the study device.
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