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| Catalog Number XXX-DURASEAL |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Infarction, Cerebral (1771); Cerebrospinal Fluid Leakage (1772); Unspecified Infection (1930)
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Event Type
Injury
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Manufacturer Narrative
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It is unknown if the device will be returned to the manufacturer for evaluation.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.
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Event Description
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In the clinical article "preserve or sacrifice the stalk? endocrinological outcomes, extent of resection, and recurrence rates following endoscopic endonasal resection of craniopharyngiomas" by ordóñez-rubiano et al, published by j neurosurg volume 13; https://thejns.Org/doi/abs/10.3171/2018.6.Jns18901.Objective: gross-total resection (gtr) of craniopharyngiomas (cps) is potentially curative and is often the goal of surgery, but endocrinopathy generally results if the stalk is sacrificed.In some cases, gtr can be attempted while still preserving the stalk; however, stalk manipulation or devascularization may cause endocrinopathy and this strategy risks leaving behind small tumor remnants that can recur.Methods: a retrospective review of a prospective cohort of patients who underwent initial resection of cp using the endoscopic endonasal approach over a period of 12 years at weill cornell medical college, newyork-presbyterian hospital, was performed.Postresection integrity of the stalk was retrospectively assessed using operative notes, videos, and postoperative mri.Tumors were classified based on location into type i (sellar), type ii (sellar-suprasellar), and type iii (purely suprasellar).Pre- and postoperative endocrine function, tumor location, body mass index, rate of gtr, radiation therapy, and complications were reviewed.Results: a total of 54 patients who had undergone endoscopic endonasal procedures for first-time resection of cp were identified.The stalk was preserved in 33 (61%) and sacrificed in 21 (39%) patients.Gtr was achieved in 24 patients (73%) with stalk preservation and 21 patients (100%) with stalk sacrifice (p = 0.007).Stalk-preservation surgery achieved gtr and maintained completely normal pituitary function in only 4 (12%) of 33 patients.Permanent postoperative diabetes insipidus was present in 16 patients (49%) with stalk preservation and in 20 patients (95%) following stalk sacrifice (p = 0.002).In the stalk-preservation group, rates of progression and radiation were higher with intentional subtotal resection or near-total resection compared to gtr (67% vs 0%, p < 0.001, and 100% vs 12.5%, p < 0.001, respectively).However, for the subgroup of patients in whom gtr was achieved, stalk preservation did not lead to significantly higher rates of recurrence (12.5%) compared with those in whom it was sacrificed (5%, p = 0.61), and stalk preservation prevented anterior pituitary insufficiency in 33% and diabetes insipidus in 50%.Conclusions: while the decision to preserve the stalk reduces the rate of postoperative endocrinopathy by roughly 50%, nevertheless significant dysfunction of the anterior and posterior pituitary often ensues.The decision to preserve the stalk does not guarantee preserved endocrine function and comes with a higher risk of progression and need for adjuvant therapy.Nevertheless, to reduce postoperative endocrinopathy attempts should be made to preserve the stalk if gtr can be achieved.Complications: 2 patients with csf leaks with necessary revision surgery, 1 patient with an intracranial infection, 5 patients with postoperative subjective visual worsening with revision surgery necessary, and 1 patient with severe vasospasm with bilateral deep infarctions in basal ganglia.
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Manufacturer Narrative
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Additional information - d10, g4, g7, h2, h3, h6, h10 the product was not returned for evaluation.There was no lot number identified, as such a dhr review could not be performed.At the time of manufacturing, records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications.With the information provided a root cause could not be determined, as there is no way to reliably determine why the reported condition occurred.Between 05nov2019 and 30jun2020, approximately 2,200 mdrs submitted electronically by integra lifesciences via trackwise, integra's complaint handling system, were not received by cdrh due to a computer system issue.Within this time period, an error with integra's middleware, which facilitates communications between trackwise and the fda system, caused the complaint records to close and indicate we had received an acknowledgement 3 from the fda when we had not.Integra interpreted the acknowledgement as a successful submission; however, subsequent investigation revealed the acknowledgement 3 received was from our middleware and not from the fda (these acknowledgements have been retained as part of the documentation of the mdr).The malfunction was related to the relocation of the trackwise application to a new data center during the transition of integra's corporate headquarters from plainsboro, nj to princeton, nj.Previously, integra had been successfully receiving acknowledgements 1, 2, and 3 from the fda, and our records reflect these acknowledgements, including the date and time stamps.Capa pr 229048 and nc 20-011 have been opened by integra to further investigate the nonconformance and develop a corrective action plan.The middleware error has been corrected, and integra has filed mdrs since the correction and verified that the appropriate acknowledgements have been received from the fda.Integra is resubmitting all impacted mdr reports for the time period 05nov2019 through 30jun2020.Integra lifesciences contacted (b)(4) office of product evaluation and quality on july 8-9, 2020 to report these issues regarding mdr reports.
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Search Alerts/Recalls
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