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| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Hemorrhage/Bleeding (1888); Liver Damage/Dysfunction (1954); Shock (2072); Rupture (2208); Stenosis (2263); Obstruction/Occlusion (2422); Vascular Dissection (3160); Thrombosis/Thrombus (4440); Insufficient Information (4580)
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| Event Date 10/13/2023 |
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Event Type
Injury
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Event Description
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Medtronic received a literature article titled; current endovascular management of arterial complications after pediatric liver transplantation in a tertiary center.From december 2019 to december 2022, consecutive transplanted pediatric patients who underwent endovascular treatment of hepatic artery complications were reviewed.The analysis included: type of complication (occlusion, stenosis, pseudoaneurysm); onset (acute = \15 days, subacute = 15¿90 days, late = [90days); endovascular technique (angioplasty, stenting); complications and outcomes.Technical success was defined as the opacification of the hepatic artery at the final angiogram with\ 50% residual stenosis and no pseudoaneurysms.Out of 86 liver transplant patients and 1 meso-rex surgery, seventeen patients presented with arterial complications and underwent 21 hepatic arteriography procedures for predominantly acute or subacute occlusions (n = 7) or stenosis (n = 11) with concurrent pseudoaneurysms (n = 4).Resolute onyx drug eluting stents were among a number of stents used in case of refractory obstructions.Primary and secondary technical success was achieved in 13/18 and 3/3 procedures, respectively, with overall technical success of 76%.Angioplasty alone was successful in 5/21 procedures; stent retriever thrombectomy was performed in one occlusion with thrombosis; stenting was required in 9/17 (53%) patients.Clinical success was obtained in 14/17 (82%) patients with hepatic artery patency after a median of 367 days.Clinical failure occurred in 3 permanent occlusions, with 2 deaths and 1 re-transplantation.Procedure-related complications included minor events in 3/17 (18%) patients and 1/17 (6%) death.
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Manufacturer Narrative
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Title: current endovascular management of arterial complications after pediatric liver transplantation in a tertiary center year: 2023.Reference: doi.Org/10.1007/s00270-023-03557-0 a2: average age a3: majority gender b3: date of publication medication: heparin and aspirin medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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Manufacturer Narrative
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Correction: patient deaths were also included in the results of the journal article, however no causal link suggesting that the medtronic devices used in the patient cohort may have caused or contributed to the deaths was provided.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Additional information: bleeding was a consequence of altered vascular wall that was injured by balloon angioplasty that led to hepatic artery (ha) rupture.It was confirmed that the resolute onyx device was not the cause of the bleeding, and was not deemed to be the cause of the deaths.The physician believes there was no relation between the resolute onyx and the patient deaths.Correction: the aim of this retrospective study is to report the outcomes of the interventional radiological (ir) management of arterial complications after pediatric liver transplant (lt).Technical failure was the inability to recanalize the hepatic artery or residual stenosis >50%.Clinical success was defined as grafts and patient¿s survival.Clinical failure as the unfavorable development of patient status, resorting to re-transplantation or death.The development of biliary complications was also recorded.All procedures were performed under general anesthesia.Transfemoral arterial access was established under ultrasound control using a non-medtronic (mdt) micro-puncture set.A 4f 2-shaped non-mdt catheter was placed in the celiac trunk to perform a diagnostic angiogram; the short 4 fr femoral introducer sheath was exchanged with a longer non-mdr 5 or 6 fr sheath.The use of an intermediate 5 fr non-mdt guiding catheter was considered in case of difficult anatomies.A 0.021¿0.027¿¿ id non-mdt micro-catheter was navigated in the intrahepatic branches over 0.014¿0.018¿¿ non-mdt hydrophilic guidewires.Super selective angiograms were acquired to confirm regular intrahepatic arterial branch catheterization.A 300-cm 0.014¿¿ non-mdt exchange guide wire was then advanced to support percutaneous transluminal angioplasty (pta), or stent deployment.If no bleeding occurred, heparin was intra-arterially administered before pta/stenting by intra-arterial bolus at the dose of 50¿80 units/kg.Coronary monorail or peripheral over-the-wire non-mdt balloon microcatheters were used according to the size of the target hepatic artery.The non-mdt neurovascular stent retriever was considered in case of thrombosis after pta failure.Stenting or stent-grafting was chosen in case of refractory obstructions.Stent grafting was considered in case of pseudo-aneurysms and recent surgical anastomosis.Low-molecular-weight heparin prophylaxis was maintained up to 2 weeks after the procedure.Aspirin was routinely administered for 6 months after transplant at the dosage of 5 mg/kg (up to 100 mg) daily, it was never withheld before the procedure, and indefinitely maintained after revascularization.Technical failure occurred in 5/21 (23%) procedures: in one due to arterial kinking that required surgical revision, followed by recurrent occlusion that was managed by endovascular reintervention; in two other occlusions, there was a likely underlying obstruction that couldn¿t be crossed; in one procedure, there was a severe stenosis; in the last one, there was a diffuse intra hepatic thrombosis not responsive to angioplasty.The 2 deaths were due to bleeding and multiorgan failure, respectively, of whom 1 occurred after re-transplantation.Bleeding was a consequence of angioplasty that led to hepatic artery (ha) rupture.Due to rapid deterioration of the hemodynamic status, embolization was preferred over stent grafting.One patient underwent successful re-transplantation.Liver enzymes were significantly altered in ha occlusions with a relevant post procedural increase in failed or complicated procedures.Procedure-related grade 3 complications occurring in the 3 patients included: 2 common femoral artery occlusions related to 5 fr sheath placement, which were conservatively managed thanks to spontaneous limb revascularization through collaterals.One dissection and occlusion of the common ha was compensated through the gastroduodenal artery.There was one grade 6 complication involved ha rupture leading to shock, multiorgan failure and death.Out of the 17 patients, 10 (59%) developed biliary obstructive complications, without any association with the technical and clinical success of the ir procedures.Annex e codes.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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