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| Catalog Number 201D |
| Device Problem
Unstable (1667)
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| Patient Problem
Thromboembolism (2654)
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| Event Date 03/09/2022 |
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Event Type
Injury
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Manufacturer Narrative
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Manufacturer¿s ref.No: (b)(4).Information regarding patient date of birth, weight, race, and ethnicity were not provided.The initial reporter phone: (b)(6).The initial reporter email address was not available / provided.Conclusion: the healthcare professional reported that a (b)(6) female underwent pulserider aneurysm neck reconstruction device (anrd)-assisted coil embolization of a recurrent right middle cerebral artery (mca) aneurysm and experienced intraoperative thrombus formation at the aneurysm neck.The thrombus was noted to be protruding into the parent vessel.Using a scepter percutaneous transluminal angioplasty (pta) balloon (microvention), the coil mass was pushed up to the aneurysm side, and the delivery to the aneurysm neck was improved.The thrombus also decreased, and blood flow improved, so antiplatelet drugs were prescribed.The patient's clinical course was monitored.Post-procedure, there were no remarkable findings.It was last reported that the patient is hospitalized.The attending physician's opinion on the relationship between this event and the pulserider anrd is as follows: ¿it would have been better if pulserider had been pushed more firmly into the mother's vein; because it was slightly sweet, the coil was clogged up to the very end of the aneurysm neck, and as a result, pulserider down in the mother's vein.Compared to the stent, the coil of pulserider was inserted more and more, so i attacked too much and inserted too much.Even with ordinary stent placement, thrombosis may occur.Possible causes other than the product include the effect of antiplatelet agents in advance on patients.¿ during the procedure, a benchmark¿ distal access catheter (penumbra) was advanced to the internal carotid (ic); the pulserider 8t, 2.7- 3.5mm anrd (201d / 3068658314) was inserted and deployed via a prowler select plus microcatheter (unknown product code/lot number).After the pulserider placement at the right mca, nine (9) unspecified coils were implanted via the sl-10® microcatheter (stryker) via trans-cell technique.The coil mass was falling down, and the pulserider arm was floating off the parent vessel, so the physician pushed it up a little before detachment.The position was slightly elevated, and it seemed to have improved.Therefore, the physician detached it.Detachment of the pulserider was confirmed, and then thrombus was observed at the aneurysm neck.Entrapment of the coil mass to the parent vessel and a small amount of thrombus were confirmed.The patient¿s condition was monitored every 10 to 15 minutes, but no decrease in thrombus was observed.As a result, a scepter pta balloon (microvention) was used to push the coil mass to the aneurysm.Contrast imaging showed improvement of blood flow, and the procedure was completed.Antiplatelet medication was administered.The pulserider anrd was allegedly used as per the instructions for use (ifu).The pulserider anrd remains implanted in the patient and is thus not available for evaluation.On (b)(6) 2022, the cerenovus sales representative provided the following additional information.Magnetic resonance (mr) confirmed that the thrombus had dissolved and the blood vessels became thicker after the procedure.The patient was discharged from the hospital without any problem as the patient was asymptomatic.The physician prescribed aspirin and efient and judged the event to be non-serious because the patient was asymptomatic after the procedure.On (b)(6) 2022, additional information received.The information indicated that anonymized images / angiographs of the procedure are not available.The size / brand / manufacturer of the nine (9) coils used during the procedure is unknown.The patient¿s vessel was not tortuous nor with acute bends.Regarding the physician comment: ¿it would have been better if pulserider had been pushed more firmly into the mother's vein (because it was slightly sweet, the coil was clogged up to the very end of the aneurysm neck, and as a result, pulserider down in the mother's vein.)¿ the following clarification was provided: ¿since the force of pushing the pulserider against the aneurysm from the parent artery was not sufficient, the coils were clogged up to the limit of the neck of the aneurysm.As a result, the pulserider came down to the parent artery.The physician said that he should have pressed the pulserider more firmly to the aneurysm.¿ the information indicated that the patient made a full recovery and was discharged from the hospital on (b)(6) 2022.Based on complaint information, the device remains implanted and is thus not available for evaluation.A review of manufacturing documentation associated with this lot (3068658314) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.The device will not be returned for analysis and therefore, no further investigation can be performed at this time.As a result, we are closing this investigation.Device instability prior to detachment is considered an mdr reportable malfunction as this device issue could lead to vessel damage, coil prolapse or migration, cerebral thrombosis, vessel occlusion, or ischemia/infarct.In this case, the alleged device instability led to cerebral thrombosis formation with the need for medical and surgical intervention to preclude permanent impairment/damage.Thus, the event meets mdr reporting criteria with the classification of ¿serious injury.¿ with the information available and with the product not available for return as it remains implanted, the issue related to instability cannot be investigated.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and without the return of the complaint sample; however, it is possible that clinical and procedural factors, including device manipulation / interaction, aneurysm size / vessel characteristics, device selection, and the concomitant microcatheter, may have contributed to the instability of the device.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective /preventive action may be triggered at a later time.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no corrective actions will be taken at this time.Missing information from this report is identified as blank; this information was not provided in the reported event or available at the time of report submission.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.
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Event Description
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The healthcare professional reported that a (b)(6) female underwent pulserider aneurysm neck reconstruction device (anrd)-assisted coil embolization of a recurrent right middle cerebral artery (mca) aneurysm and experienced intraoperative thrombus formation at the aneurysm neck.The thrombus was noted to be protruding into the parent vessel.Using a scepter percutaneous transluminal angioplasty (pta) balloon (microvention), the coil mass was pushed up to the aneurysm side, and the delivery to the aneurysm neck was improved.The thrombus also decreased, and blood flow improved, so antiplatelet drugs were prescribed.The patient's clinical course was monitored.Post-procedure, there were no remarkable findings.It was last reported that the patient is hospitalized.The attending physician's opinion on the relationship between this event and the pulserider anrd is as follows: ¿it would have been better if pulserider had been pushed more firmly into the mother's vein; because it was slightly sweet, the coil was clogged up to the very end of the aneurysm neck, and as a result, pulserider down in the mother's vein.Compared to the stent, the coil of pulserider was inserted more and more, so i attacked too much and inserted too much.Even with ordinary stent placement, thrombosis may occur.Possible causes other than the product include the effect of antiplatelet agents in advance on patients.¿ during the procedure, a benchmark¿ distal access catheter (penumbra) was advanced to the internal carotid (ic); the pulserider 8t, 2.7- 3.5mm anrd (201d / 3068658314) was inserted and deployed via a prowler select plus microcatheter (unknown product code/lot number).After the pulserider placement at the right mca, nine (9) unspecified coils were implanted via the sl-10® microcatheter (stryker) via trans-cell technique.The coil mass was falling down, and the pulserider arm was floating off the parent vessel, so the physician pushed it up a little before detachment.The position was slightly elevated, and it seemed to have improved.Therefore, the physician detached it.Detachment of the pulserider was confirmed, and then thrombus was observed at the aneurysm neck.Entrapment of the coil mass to the parent vessel and a small amount of thrombus were confirmed.The patient¿s condition was monitored every 10 to 15 minutes, but no decrease in thrombus was observed.As a result, a scepter pta balloon (microvention) was used to push the coil mass to the aneurysm.Contrast imaging showed improvement of blood flow, and the procedure was completed.Antiplatelet medication was administered.The pulserider anrd was allegedly used as per the instructions for use (ifu).The pulserider anrd remains implanted in the patient and is thus not available for evaluation.On (b)(6) 2022, the cerenovus sales representative provided the following additional information.Magnetic resonance (mr) confirmed that the thrombus had dissolved and the blood vessels became thicker after the procedure.The patient was discharged from the hospital without any problem as the patient was asymptomatic.The physician prescribed aspirin and efient and judged the event to be non-serious because the patient was asymptomatic after the procedure.On (b)(6) 2022, additional information received.The information indicated that anonymized images / angiographs of the procedure are not available.The size / brand / manufacturer of the nine (9) coils used during the procedure is unknown.The patient¿s vessel was not tortuous nor with acute bends.Regarding the physician comment: ¿it would have been better if pulserider had been pushed more firmly into the mother's vein (because it was slightly sweet, the coil was clogged up to the very end of the aneurysm neck, and as a result, pulserider down in the mother's vein.)¿ the following clarification was provided: ¿since the force of pushing the pulserider against the aneurysm from the parent artery was not sufficient, the coils were clogged up to the limit of the neck of the aneurysm.As a result, the pulserider came down to the parent artery.The physician said that he should have pressed the pulserider more firmly to the aneurysm.¿ the information indicated that the patient made a full recovery and was discharged from the hospital on (b)(6) 2022.
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Manufacturer Narrative
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Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the additional event information received on 28-mar-2022.[additional information]: on 28-mar-2022, additional information was received.The information indicated that continuous flush was maintained during the pulserider-assisted coil embolization procedure.A singular image of the procedure was also included.The imaging included in the complaint underwent independent physician review on 29-mar-2022.The results of the physician review are documented as follows: ¿the description of the case and the provided image was reviewed.From the image it is clear that a coil mesh is placed in the mca aneurysm on the right side.Furthermore, there is a pulserider device placed in the parent vessel with the petals/wings being covered by the coils so the position cannot be determined.There seems to be adequate distal flow and a normal vessel caliber distal to the aneurysm.The clot that is described is not visible in this single image, knowing that further images are not available.Based on the verbal description it is impossible to determine where the clot originated; either on the pulserider or within the coil mesh.These thrombotic events are known in aneurysm treatment and the way it was handled by the physician is according to common practice.¿ physician name and date reviewed: (b)(6) md, neurointerventionalist.29-mar-2022.Updated sections: b.4, g.3, g.6, h.2, and h.10.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.
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Manufacturer Narrative
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Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the additional event information received on 06-apr-2022.[additional information]: on 06-apr-2022, additional information was received.The information indicated that anonymized images / angiographs of the procedure will be made available when the cerenovus sales rep is able to obtain them.The nine (9) coils in the following order were implanted using the sl-10 microcatheter via the transcell: 3.5mm x 7.5cm galaxy g3, 3mm x 6cm galaxy g3 xsft, 3mm x 8cm xsft complex smart coil (penumbra), 2.5mm x 6cm wave smart coil (penumbra), 2.5mm x 6cm wave smart coil (penumbra), 2mm x 4cm galaxy g3 mini, 2mm x 3cm wave smart coil (penumbra), 1.5mm x 3cm wave smart coil(penumbra), and 1mm x 2cm wave smart coil (penumbra).The information also provided clarification to the statement by the physician, ¿it would have been better if pulserider had been pushed more firmly into the mother's vein (because it was slightly sweet, the coil was clogged up to the very end of the aneurysm neck, and as a result, pulserider down in the mother's vein.)¿ due to the force of pushing the pulserider against the aneurysm from the parent artery not being sufficient, the coils were clogged up to the limit of the aneurysm neck resulting in the pulserider coming down to the parent artery.The physician commented that he should have pressed the pulserider more firmly to the aneurysm.The vessel was not excessively tortuous nor with acute bends.Continuous flush was maintained.The patient made a full recovery and was discharged from the hospital on (b)(6) 2022.Based on the additional information provided on 06-apr-2022, three of the nine coils implanted using the sl-10 microcatheter via transcell were cerenovus coils.The three coils are: 3.5mm x 7.5cm galaxy g3 (gly123575 / lot# unk), 3mm x 6cm galaxy g3 xsft (glx120306 / lot# unk), and 2mm x 4cm galaxy g3 mini (glm920040 / lot# unk).This is one of 4 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2022-00189, 3008114965-2022-00273, 3008114965-2022-00274, and 3008114965-2022-00275.Updated sections: b.4, g.3, g.6, h.2, h.10, and concomitant products.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.
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