MAUDE Adverse Event Report: SEE H.10 HELI 18 CERE, 6MMX20CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	CHE18062030
Medical Device Problem Codes	Material Fragmentation (1261); Premature Activation (1484); Unraveled Material (1664)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Information regarding patient race and ethnicity were not provided.(b)(4).Concomitant med products: terumo hydrophilic progreat.021 in micro 2.4-2.9 fr.022 in 130 cm marker band; medtronic amplatz gooseneck snare.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.The device has not been returned.If the device returns, a device investigation will be performed.Additional information will be submitted within 30 days of receipt.
Event or Problem Description
The healthcare professional reported the helipaq 18 cerecyte coil 6 mm x 20 cm (che18062030 / c39043) was the third coil used during the embolization procedure to treat an endovascular leak in the (b)(6) male patient post-endovascular repair of an aortic aneurysm.The first coil was deployed, the second coil was retrieved.The helipaq coil was advanced in the deployment microcatheter (hydrophilic progreat.021 in micro 2.4-2.9fr.022 in 130 cm marker band) via the accessed l1 artery to the site where deployment was desired within the aortic aneurysm sac; the coil was determined to be too long and the physician made the decision to retract the coil rather than to deploy it.There was resistance between the deployment microcatheter and the helipaq 18 cerecyte coil during the retraction of the coil through the deployment microcatheter.The resistance encountered by the helipaq 18 cerecyte coil was reported to be the same amount of resistance that the second retrieved coil encountered through the long tortuous path that the catheter followed.It became apparent that the coil was not retracting despite pulling on the deployment wire.The coil appeared to unravel.The physician decided to pull the microcatheter with the coil out through the 5f guiding catheter.The microcatheter came out but the coil remained in the patient partially deployed in the aortic sac extending back through the l1 artery into the aortic lumen.The bulk of the unraveled coil within the aortic lumen was removed using various techniques including a snare device (medtronic amplatz gooseneck snare).A tiny, very fine wire fragment remains protruding 10-20 mm in to the aortic lumen.The procedure was completed with the first coil that was deployed within the endoleak flow channel and with the partially deploy portion of the helipaq coil.No additional coils were placed.It was confirmed that the reported event did not result in any interruption in blood flow.There was no kink on the microcatheter that might have contributed to the event; there was adequate and continuous flush maintained through the catheter.It was also confirmed that the coil was not positioned at a relative sharp angle to the microcatheter.It is anticipated that the helipaq 18 cerecyte coil will be returned for analysis; however, the concomitant microcatheter had been discarded.There was no report of patient injury or complication, no procedural delay; the patient was discharged the afternoon of the procedure with a follow-up in four weeks.
Additional Manufacturer Narrative
Manufacturer¿s ref no: (b)(4).[complaint conclusion]: the healthcare professional reported the helipaq 18 cerecyte coil 6mm x 20cm (che18062030 / c39043) was the third coil used during the embolization procedure to treat an endovascular leak in the 67-year old male patient post-endovascular repair of an aortic aneurysm.The first coil was deployed, the second coil was retrieved.The helipaq coil was advanced in the deployment microcatheter (hydrophilic progreat.021 in micro 2.4-2.9fr.022 in 130cm marker band) via the accessed l1 artery to the site where deployment was desired within the aortic aneurysm sac; the coil was determined to be too long, and the physician made the decision to retract the coil rather than to deploy it.There was resistance between the deployment microcatheter and the helipaq 18 cerecyte coil during the retraction of the coil through the deployment microcatheter.The resistance encountered by the helipaq 18 cerecyte coil was reported to be the same amount of resistance that the second retrieved coil encountered through the long tortuous path that the catheter followed.It became apparent that the coil was not retracting despite pulling on the deployment wire.The coil appeared to unravel.The physician decided to pull the microcatheter with the coil out through the 5f guiding catheter.The microcatheter came out but the coil remained in the patient partially deployed in the aortic sac extending back through the l1 artery into the aortic lumen.The bulk of the unraveled coil within the aortic lumen was removed using various techniques including a snare device (medtronic amplatz gooseneck snare).A tiny, very fine wire fragment remains protruding 10-20 mm in to the aortic lumen.The procedure was completed with the first coil that was deployed within the endoleak flow channel and with the partially deploy portion of the helipaq coil.No additional coils were placed.It was confirmed that the reported event did not result in any interruption in blood flow.There was no kink on the microcatheter that might have contributed to the event; there was adequate and continuous flush maintained through the catheter.It was also confirmed that the coil was not positioned at a relative sharp angle to the microcatheter.It is anticipated that the helipaq 18 cerecyte coil will be returned for analysis; however, the concomitant microcatheter had been discarded.There was no report of patient injury or complication, no procedural delay; the patient was discharged the afternoon of the procedure with a follow-up in four weeks.Investigation summary: the device was returned with its inner pouch.Labeling on the inner pouch matches the product documented in the complaint.Three segments of embolic coil were returned.The embolic coil is stretched.The primary segment of embolic coil is tangled.The embolic coil is detached from the device positioning unit (dpu).The device has been partially unsheathed.The dpu core wire is protruding from the skive of the translucent introducer sheath.The resheathing tool is broken.The dpu core wire is kinked or bent at the strain relief and approximately 22 cm, 24 cm, 52 cm, 79 cm, 97 cm, and 129 cm from the proximal end.The resistance heating (rh) coil has not heated.The detachment fiber is broken, indicating that the embolic coil detached mechanically.The v-notch of the resheathing tool is undamaged.There is necking present in some of the broken ends, indicative of ductile fractures.Other broken ends are pinched and smooth-ended, indicating that the device was likely cut.The main mass of embolic coil is stretched and tangled.There is blood on the embolic coil.Advancement cannot be tested because the embolic coil is detached from the dpu.A review of the manufacturing documentation associated with this lot: (c39043) presented no issues during the manufacturing, packaging, or inspection processes related to the reported complaint.There were no nonconformances related to device packaging.Investigation conclusion: the complaint that the embolic coil is stretched is confirmed.The embolic coil is severely stretched.The complaint that the embolic coil is separated is confirmed.Three segments of embolic coil were returned, and the event description records that a fourth segment remains implanted.The complaint that the embolic coil detached prematurely is confirmed.The rh coil has not heated, and damage to the detachment fiber indicates that the embolic coil detached mechanically.The complaint of resistance or friction cannot be confirmed.Advancement could not be tested because of the severe damage to and detachment of the embolic coil.The broken resheathing tool and kinks in the dpu core wire are indicative of the application of excessive force, either during advancement of the device or in manipulation in an attempt to remove the device against resistance.Mechanical detachment and stretching of the embolic coil are indicative of the application of excessive force during retraction.In addition, necking observed at two of the broken ends of the returned embolic coil suggests that excessive retraction force was applied to the point where a ductile fracture was created in the embolic coil.According to the event description, the user observed that the embolic coil may have begun to stretch during an attempt to remove it from the aneurysm.When the decision was made to remove the embolic coil, device was with the microcatheter, the user noted that the embolic coil remained behind.It is likely that this is the point at which the embolic coil detached mechanically from the dpu.Separation of the embolic coil into segments appears to have occurred during recovery of the stretched embolic coil after detachment.Recovery techniques are likely to have placed excessive force on the embolic coil, causing it to break in several locations.The tangled mass of embolic coil may have been formed while it was being recovered or after it was recovered.While the complaint of resistance or friction cannot be confirmed due to the condition of the returned device, stretching can occur when excessive retraction force is applied to a device in the presence of resistance.No source of resistance can be identified in the returned device because of the severe damage caused during recovery of the detached and stretched embolic coil.However, the event description documents that the embolic coil was being deployed into an aneurysm that was leaking following a prior endovascular aneurysm repair.It is possible that the resistance was generated in this repaired aneurysm that prevented the embolic coil from retracting easily.Device history lot: a review of the manufacturing documentation associated with this lot: (c39043) presented no issues during the manufacturing, packaging, or inspection processes related to the reported complaint.There were no nonconformances related to device packaging.The device history record review was performed, and it did not suggest that the reported failure could be related to the manufacturing process of the product.The exact cause of the event could not be conclusively determined; however, it is possible that the reported resistance encountered by the helipaq 18 cerecyte coil was generated in the repaired aortic aneurysm that prevented the coil from being easily retrieved/retracted which resulted in the coil becoming unraveled, with a portion of the coil remained in the patient partially deployed in the aortic sac.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.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.

• Brand Name: HELI 18 CERE, 6MMX20CM
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): SEE H.10; 47709 fremont blvd; fremont CA 94538
• MDR Report Key: 7670771
• Report Number: 3008114965-2018-00654
• Device Sequence Number: 13682974
• Product Code: HCG
• UDI-Device Identifier: 00878528000761
• UDI-Public: 00878528000761
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K082739
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2020
• Device Catalogue Number: CHE18062030
• Device Lot Number: C39043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2018
• Initial Date Received by Manufacturer: 06/14/2018
• Supplement Date Received by Manufacturer: 07/10/2018
• Initial Report FDA Received Date: 07/09/2018
• Supplement Report FDA Received Date: 08/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 69