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Lot Number PD18100001 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Seroma (2069)
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Event Date 08/31/2020 |
Event Type
Injury
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Manufacturer Narrative
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The graft remains implanted.Therefore, our investigation is based on a comprehensive records re-review.Once the results of investigation are available, a follow up report will be submitted.
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Event Description
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Rti surgical, inc (rti) and tutogen medical (b)(4), a wholly owned subsidiary of rti, received a complaint on 09/28/2020, as part of the fortiva appear trial.The reported complaint indicated that on (b)(6) 2020, a (b)(6) year old female patient underwent a right sided nipple conserving inframmary mastectomy due to stage ia breast cancer.A silicone implant was placed and a fortiva porcine dermis was implanted.Four lymph nodes were removed.Two drains were placed, one in hte axilla and one in the breast.The drains were removed on (b)(6) 2020 when fluid drainage was less than 30cc/day and the patient was discharged home without medications.On (b)(6) 2020, the patient developed a seroma requiring multiple drainings that did not require hospitalization.It was reported that this event was considered resolved on (b)(6) 2020.
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Manufacturer Narrative
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Rti germany conducted a batch documentation review for serial id (b)(6) manufactured from lot pd18100001.One departure from the standard operating procedures was noted during the records re-review for the lot (alerting deep freezer (no.950) - no impact on the product as the tissue was restored immediately in another freezer and the temperature was constantly -40°c.Manufacturing records review indicated that serial id (b)(6) was manufactured to specification and met all acceptance / inspection criteria prior to distribution.To date, rti germany has manufactured and distributed a total of 51 fortiva® 1mm perforated xenografts from the lot.There are six related complaints associated with lot pd18100001 and the fortiva appear trial (reference complaints (b)(4).Although implant therapy is highly successful and predictable, it is not without possible early and/or late complications.Seroma formation has frequently been reported to occur post-operatively, especially when lymphatic vessels have been cut.Seroma formation may also be caused by decreased blood supply at the surgical site, poor soft tissue coverage, and/or high activity level post-operatively.Often drains are placed during the surgical procedure to prevent seroma formation.The surgical procedures (mastectomy and breast reconstruction) and/or placement of the silicone implant could be considered a confounding factor to seroma development.In this specific case, two drains had been placed and four lymph nodes were removed on the right side.It is more plausible that the patient's adverse event was associated with a source or event extrinsic to the xenograft implant.
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Search Alerts/Recalls
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