The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.The complainant indicated that the device is retained and will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
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It was reported to boston scientific corporation that a xenform soft tissue repair matrix was used during a rectocele repair procedure performed on an unknown date in (b)(6) 2016.According to the complainant, the xenform "failed" and the rectocele returned, so a procedure was performed on (b)(6) 2017 to remove the xenform mesh from the patient and replace it with polyform.During this procedure, it was found that the xenform was torn in two pieces inside the patient, and these two pieces were removed from the patient.The doctor tried to tear the removed xenform, but it was still strong.However, it didn't appear as any ingrowth had occurred and it reportedly almost looked new.All other information is unknown.Should additional relevant details become available; a supplemental report will be submitted.
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