MAUDE Adverse Event Report: REFER TO SECTION H10 DELTAFILL18 12MM X 42CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	DLF181242
Medical Device Problem Codes	Material Separation (1562); Material Protrusion/Extrusion (2979); Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/22/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Information regarding patient weight, medical history, race, and ethnicity was not provided.Procode: krd/hcg.Physical manufacturer name: codman and shurtleff inc., dba depuy synthes products, inc.((b)(4)) it was not reported whether the device is available for evaluation and testing and it has not been received to date.Concomitant med products due to character limitation: sl-10 (stryker) microcatheter, navien (medtronic) support catheter.Initial reporter phone, fax, and e-mail was not provided.Physical manufacturer name: codman and shurtleff inc., dba depuy synthes products, inc.((b)(4)) 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 company is seeking this information through the event investigation.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.
Event or Problem Description
As reported by a healthcare professional, during a stent-assisted coil embolization of a 12x6mm anterior communicating artery (aca) aneurysm, the 12mm x 42cm deltafill18 ((b)(4)) thermo-mechanical coil was detached from the guide it was attached to when the physician attempted to rewind it to get its position inside the aneurysm.They began to rewind it by pulling the guide outwards and they were rewinding approximately 20 cm from the coil and at that moment they noticed that the guide was still coming out and the coil was not moving until they completely removed the guide.Half of the coil was inside the aneurysm and half inside the navien catheter.They used a sl-10 microcatheter from stryker.When they observed that the coil had detached from the guide, they also saw that within the navien catheter there were strands detached from the guide that is attached to the coil and the coil.They had to use an amplatz loop snare to remove the detached "pads".In the first pass, they extracted the loose strands with great difficulty and in the second pass the coil.They believed that they managed to remove all the detached parts.They proceeded with the case by filling the aneurysm with competitor coils.There was no report of consequence or impact to the patient.Of note, the target aneurysm was not previously treated.Two y-configured neuroform stents were initially placed.A target coil was then placed but seemed too rigid so the physician decided to continue with the 12mm x 42cm deltafill18 thermo-mechanical coil.It is not reported whether the product would be returned for analysis.No further information was provided.
Additional Manufacturer Narrative
Product complaint # (b)(4).Complaint conclusion: as reported by a healthcare professional, during a stent-assisted coil embolization of a 12 x 6mm anterior communicating artery (aca) aneurysm, the 12mm x 42cm deltafill18 (dlf181242/l10298) thermo-mechanical coil was detached from the guide it was attached to when the physician attempted to rewind it to get its position inside the aneurysm.Initially, the aneurysm was stented with 2 y-configured neuroform stents.A target coil was then placed but seemed too rigid, so the physician decided to continue with the 12mm x 42cm deltafill18 thermo-mechanical coil.After placing the coil in the aneurysm, they began to rewind it by pulling the guide outwards and they were rewinding approximately 20 cm from the coil and at that moment they noticed that the guide was still coming out and the coil was not moving until they completely removed the guide.Half of the coil was inside the aneurysm and half inside the navien catheter.They used a sl-10 microcatheter from stryker.When they observed that the coil had detached from the guide, they also saw that within the navien catheter there were strands detached from the guide that is attached to the coil and the coil.They had to use an amplatz loop snare to remove the detached "pads".In the first pass, they extracted the loose strands with great difficulty and in the second pass the coil.They believed that they managed to remove all the detached parts.They proceeded with the case by filling the aneurysm with competitor coils.There was no report of consequence or impact to the patient.The target aneurysm was not previously treated.No further information was provided.The device was returned with its inner pouch.Labeling on the inner pouch matched the product documented in the complaint.The embolic coil was not attached to the device positioning unit (dpu).The distal end of the dpu was located in the translucent introducer sheath.The device was mostly sheathed.Approximately 9 cm of the dpu core wire was protruding from the skive of the translucent introducer sheath.At the proximal end of the protrusion, there was a kink in the dpu core wire, approximately 124 cm from the proximal end of the device.There was also a kink in the dpu core wire approximately 7 cm from the proximal end.The embolic coil was detached from the dpu.The condition of the resistance heating (rh) coil was obscured by the translucent introducer sheath.The dpu core wire passed through the skive of the translucent introducer sheath at both ends of the protruded section.The v-notch of the resheathing tool was undamaged.The dpu was advanced out of the introducer to visualize its distal end.The detachment fiber was broken.The rh coil had not heated.A review of manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.The complaint that the embolic coil was separated could not be confirmed.The embolic coil was detached from the dpu and was not returned.Based on the initial information received, it appeared that the coil had separated, but based on the condition of the returned device, it may have also become mechanically detached.The complaint of protrusion into the parent vessel could not be confirmed because it is procedure-specific, and procedural images were not submitted.The complaint of positioning difficulty could not be confirmed because it is situationally dependent and cannot be reproduced or tested in the lab.However, the dpu core wire was kinked, and kinks in the dpu core wire can lead to positioning difficulty.Kinks in the dpu core wire are indicative of the application of excessive force, often during advancement.100% of devices are inspected for kinks in the dpu assembly at final quality control (qc) inspection.Thus, it is unlikely that the device left the manufacturing facility with the observed kinks in the dpu core wire.The protrusion of the dpu core wire from the skive of the translucent introducer sheath is most likely the result of attempting to re-sheath the device over the observed kink in the dpu core wire.As returned, the embolic coil was detached from the device and was not returned.The rh coil had not heated, and the broken detachment fiber could be observed at the end of the dpu, indicating that the embolic coil detached mechanically.Mechanical detachment is generally the result of application of excessive retraction force to the device in the presence of resistance.The cause of resistance cannot be concluded from the event description or from the condition of the returned device.Coil separation and/or detachment, coil protrusion into the parent vessel and positioning difficulty are known procedural complications associated with the deltafill thermo-mechanical coil.The instructions for use (ifu) cautions ¿do not attempt to use the microcoil system as a guidewire if positioning of the microcatheter is lost during microcoil deployment.If repositioning of the microcoil is necessary, carefully observe the motion of the micorcoil in respect to the device positioning unit (dpu) wire while retracting the microcoil under fluoroscopy.If the microcoil movement is not one-to-one with the dpu wire, or if repositioning is difficult, the microcoil may have become stretched and could possibly break.Gently remove and discard the microcoil system.¿ multiple attempts were made without success to obtain additional information.Furthermore, it is not possible to determine if the damage found during analysis, including coil mechanical detachment, may have occurred during post-procedure handling/shipping.Based on the minimal information provided, it appears this aneurysm was located at a bifurcation requiring y-stenting.This type of aneurysm is more difficult to treat.The stents are intended to assist with retaining the coils within the aneurysm.It is possible that clinical/procedural factors, including patient anatomy/vessel characteristics, device selection, device manipulation, and the concomitant devices, may have contributed to the reported event; however, due to the lack of procedural information and based on the analysis, a definitive root cause conclusion regarding the reported failure cannot be determined.With review of the analysis and the device history records, there is no indication of any device manufacturing issues related to the reported event or the damages found on the returned 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 events were 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: DELTAFILL18 12MM X 42CM
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): REFER TO SECTION H10; 47709 fremont blvd; fremont CA 94538
• MDR Report Key: 7609481
• Report Number: 3008114965-2018-00648
• Device Sequence Number: 1555747
• Product Code: KRD
• UDI-Device Identifier: 10886704077121
• UDI-Public: 10886704077121
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K150319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2018

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: 09/30/2020
• Device Catalogue Number: DLF181242
• Device Lot Number: L10298
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2018
• Initial Date Received by Manufacturer: 05/25/2018
• Supplement Date Received by Manufacturer: 08/17/2018
• Initial Report FDA Received Date: 06/18/2018
• Supplement Report FDA Received Date: 08/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR