| Model Number GLM910020 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problem
Stroke/CVA (1770)
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| Event Date 09/07/2019 |
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Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).Patient identifier: (b)(6) procode: krd/hcg.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.This is one of nineteen products involved with the complaint and the associated manufacturer report numbers are 3008114965-2020-00331, 3008114965-2020-00332, 3008114965-2020-00333, 3008114965-2020-00334, 3008114965-2020-00335, 3008114965-2020-00336, 3008114965-2020-00337, 3008114965-2020-00338, 3008114965-2020-00339, 3008114965-2020-00340, 3008114965-2020-00341, 3008114965-2020-00342, 3008114965-2020-00343, 3008114965-2020-00344, 3008114965-2020-00346, 3008114965-2020-00347, 3008114965-2020-00348 and 3008114965-2020-00349.
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Event Description
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As reported via the (b)(6) study, a (b)(6) year old female (subject (b)(6) with a history of headaches, migraines, and anxiety presented with a subarachnoid hemorrhage (hunt & hess grade 2) on (b)(6) 2019 and subsequently underwent balloon-assisted coil embolization of a ruptured anterior communicating artery (acom) bifurcation aneurysm on (b)(6) 2019.Immediate pre-procedure angiography on (b)(6) 2019 revealed a ruptured midline acom bifurcation aneurysm with the following dimensions: height 5.7 mm, dome 8.1 mm, maximum aneurysm diameter 8.1 mm, neck size 2.8 mm, and dome-to-neck ratio 2.9 mm.The parent vessel diameter was 2.2 mm.Balloon-assisted coil embolization was subsequently performed with the implantation of one 4 mm x 10 cm galaxy g3 xsft (glx120410/unknown lot #), one 2.5 mm x 5 cm galaxy g3 xsft (glx122505/ l13333), one 2 mm x 2 cm galaxy g3 xsft (glx120202/l13330), one 2.5 mm x 4.5 cm galaxy g3 mini (glm925045/s15174), one 1.5 mm x 2.5 cm galaxy g3 mini (glm915025/l15425), one 1.5 mm x 3 cm galaxy g3 mini (glm915030/l14685), one 1.5 mm x 2 cm galaxy g3 mini (glm915020/l15571), two 1 mm x 2 cm galaxy g3 mini (glm910020/l14855), two 1 mm x 2.5 cm galaxy g3 mini (glm910025/l13971), one 1 mm x 1.5 cm galaxy g3 mini (glm910015/l15387), two 1 mm x 3 cm galaxy g3 mini (glm910030/l15394), one 1 mm x 1.5 cm galaxy g3 mini (glm910015/l15387), one 1 mm x 4 cm galaxy g3 mini (glm910040/l13972), one 1 mm x 1 cm galaxy g3 mini (glm910010/l14214), and one 1.5 mm x 2 cm target 360 nano (stryker) via an excelsior sl-10 (stryker) microcatheter.Heparin was administered during the procedure.Per the case report form (crf), one 5 mm x 10 cm galaxy g3 (gly120510/l12749) and one 1 mm x 1 cm galaxy g3 mini (glm910010/l14214) were used but not implanted and microcatheter kickback (loss of access to aneurysm) was encountered once during the procedure (additional information is pending).In the opinion of the investigator, treatment of the target aneurysm was considered complete with modified raymond-roy score of class ii: residual neck.The study coils were successfully implanted at the target site with 11.44 % angiosuite packing density.A mild thrombotic event was observed angiographically at an unspecified time during the procedure and resolved with intra-arterial tirofiban (aggrastat).The patient was reportedly asymptomatic.Per the principal investigator (pi), the thrombotic event was probably related to the study device.Modified information received from the clinical database on 18-jul-2020 indicated that this adverse event (ae) was inactivated with reason code ¿added in error¿ (additional information is pending).The patient was discharged home with self-care on (b)(6) 2019 with modified rankin scale (mrs) score of 0.The 180-day follow-up digital subtraction angiography (dsa) performed on (b)(6) 2020 showed modified raymond-roy score of class i: complete obliteration.The 180-day follow-up visit was conducted via phone on (b)(6) 2020; mrs score was 0.
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Manufacturer Narrative
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Product complaint #(b)(4).Updated sections of this report: b5, g4, g7, h2, h6, h10 and concomitant product the purpose of this mdr is to include the additional event information received on (b)(6)2020.The additional event information resulted in a change in the reportability of this complaint.The coil had not been introduced into the patient at the time of thrombosis diagnosis and there was no report of increase in size or dislodgement of the thrombus mass.Therefore, it has been deemed not reportable.No further reports will be forthcoming.Section b5: additional event information received indicated that the thrombotic event was inactivated as a study reportable event because the event was considered by the pi as mild in severity (non-serious).The event occurred post-coil #7 (1.5mm x 2.0cm galaxy g3 mini from lot l15571).There were no reported device malfunctions or performance issues, such as coil protrusion, associated with the event.Per investigator dictation, ¿the coil mass is well placed within the aneurysm.There is occlusion of the anterior and mid dome.There is a stagnant flow in the right aspect of the posterior dome.There is no evidence of unwanted thrombus formation or non-target embolization.Note is made of thrombus formation at the junction of the aneurysm neck and right a2 segment.¿ the thrombus was not flow-limiting and did not result in distal embolization, parent artery or side branch vessel occlusion.It was further stated that there were no clear device related issues as it is well known that patients with a ruptured aneurysm are prone to unintended clot formation and cannot be pre-treated with antiplatelets due to bleed.At this time, it cannot be recalled why the 1mm x 1cm galaxy g3 mini coil from lot l14214 was used but not implanted; however, the 5mm x 10cm galaxy g3 coil from lot l12749 was ultimately not implanted due to microcatheter kickback.A 4.0mm x 11mm scepter xc (microvention) balloon was utilized for neck remodeling.A total of (b)(4) cerenovus and 5 stryker coils were implanted in the patient (total (b)(4) ).The correct lot number of the 4mm x 10cm galaxy g3 xsft is l15630.No further information was provided.The device remains implanted; therefore, no further analysis can be performed.A manufacturing record evaluation was performed for the finished device l14855 number, and no non-conformances related to the reported complaint condition were identified.
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Search Alerts/Recalls
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