Lot Number PD18100001 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Wound Dehiscence (1154); Hypersensitivity/Allergic reaction (1907); Seroma (2069); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 11/18/2020 |
Event Type
Injury
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Manufacturer Narrative
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At this time the investigation is pending a comprehensive records review.When the information is provided a follow-up will be submitted.
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Event Description
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Rti surgical, inc (rti) and tutogen medical gmbh (tmi), a wholly owned subsidiary of rti, received a complaint as part of the fortiva appear trial.The reported complaint indicated that a patient underwent a left breast reconstruction with implantation of a fortiva porcine dermis graft and a silicone implant on (b)(6) 2019.The patient developed nipple necrosis to the left breast requiring surgical debridement on (b)(6) 2020.She was treated with antibiotics.The affected area continued to break down leading to dehiscence on (b)(6) 2020.On (b)(6) 2020, further nipple debridement was performed, as well as removal of the silicone implant and changed to a tissue expander.The fortiva xenograft remains implanted.The patient was discharged on (b)(6) 2020 (a med watch was submitted reference to the intial event reference med watch # (b)(4).On b)(6) 2021, additional information was received (serial id# b)(4), lot# pd18100001) that reported ongoing "bunching and hardening" of the matrix in the left breast, which the surgeon made an effort to reduce but some still remains.The patient is awaiting fat grafting to also help with this.
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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.There were no departures noted during records re-review that would negatively impact the manufacturing of the porcine dermis grafts.To date, rti germany has manufactured and distributed a total of 51 fortiva dermis grafts from the lot.There are six related complaints for the lot pd18100001 that are related to the fortiva clinical study.According to records re-review the product was manufactured according to rti germany's specification sp-61100 "04", annex 1-3 "06", annex 1-6 "02".The development of a post-operatively edema (swelling) is a well-known phenomenon following a breast reconstruction by using a fortiva.It may be caused by patient individual reasons (e.G.Hypersensitivity to the material) by the surgical procedure itself or e.G.By an additionally inserted device (e.G.The silicone implant or device).
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Event Description
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This follow-up submitted as rti received incorrect information from the facility and we are submitting a correction/follow up to correct (complaint number, description and patient information) rti surgical, inc (rti) and tutogen medical gmbh (tmi), a wholly owned subsidiary of rti, received a complaint as part of the fortiva appear trial.The reported complaint indicated that a patient underwent a breast reconstruction with implantation of a fortiva porcine dermis at an unknown date.On (b)(6) 2020, the patient developed a large swelling on the breast post-operative.Concerned it was a hematoma, the patient underwent a surgical exploration.No hematoma was found but there was edema present.Per reported complaint, the edema is most likely a reaction to the wash out when the patient had a wash out and the swelling subsided and wound reclosed.The patient was treated with antihistamines.On 12/09/2021: additional information was provided to rti which indicated that the patient developed an allergic reaction to implant materials.
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Event Description
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Rti germany received additional information indicating the following: the patient is a 47-year-old female who underwent a right breast reconstruction post mastectomy on (b)(6) 2020.A fortiva® graft was implanted and a 370cc silicone implant was placed.One drain remained indwelling and was removed on (b)(6) 2020.Several hours post-operatively, the patient developed a suspected allergic reaction to fortiva® adm.Prick test results for the fortiva porcine matrix were negative.On (b)(6) 2021, the fortiva® graft was removed as a preventative measure and replaced with an artia¿ reconstructive tissue matrix (same tissue matrix that's implanted in her left breast).
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Manufacturer Narrative
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Although implant therapy is highly successful and predictable, it is not without possible early and/or late complications.The fortiva® graft was removed as a preventative measure 317 days post-operatively and not assessed to have been necessary.The fortiva® graft was replaced with an artia¿ reconstructive tissue matrix (same tissue matrix that's implanted in her left breast).The graft removal event was unrelated to the fortiva® implant.
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Event Description
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Rti germany received additional information indicating the following: on (b)(6) 2020, prior to the fortiva® graft being removed, the patient developed a seroma on the right side.It is unknown if the adverse event is related to the graft.The adverse event is related to the procedure.
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Manufacturer Narrative
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A comprehensive records re-review is being conducted.Once the results are available, a fourth follow-up report will be submitted.
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Search Alerts/Recalls
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