MAUDE Adverse Event Report: SEE H.10 PRESIDIO 10 CERE 5MMX17CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number PC410051730

Device Problems Premature Activation (1484); Stretched (1601); Material Protrusion/Extrusion (2979)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/16/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Information regarding patient age, gender, weight, race, ethnicity, and medical history were not provided.This is one of 3 number of products involved with the reported complaint.The associated manufacturer report numbers are: this report, 1226348-2018-00596, and 3008114965-2018-00636.(b)(4).Concomitant med products: envoy 6f, xb mpd, stryker synchro.014 guidewire, stryker atlas stents, stryker sl-10 microcatheter, and prowler select lpes 90 deg tip.The initial reporter email and phone are not known.The device has been received and is pending evaluation.Additional information will be submitted within 30 days of receipt.

Event Description

The healthcare professional reported that during the stent-assisted coil embolization procedure to treat a recurring (recanalized) 5 mm basilar tip aneurysm that had been previously treated with an enterprise stent (catalog and lot numbers unavailable) through the right posterior communicating artery (pca) with micrus coils (catalog and lot numbers unavailable), the physician determined that a second stent through the left pca was needed and successfully deployed a stryker atlas stent through the sl-10 microcatheter.The sl-10 microcatheter was then exchanged for the prowler select lp microcatheter and accessed the aneurysm.The presidio 10 cere 5 mm x 17 cm coil (pc410051730 / s12089) was deployed into the aneurysm and during deployment of the coil, the microcatheter purchased into the aneurysm and was lost several times.Each time the microcatheter purchased and lost, the coil was used as a guidewire for the microcatheter to climb over and back into the aneurysm.At one point, with 2 cm of the coil in the aneurysm, the coil became stuck and could not be advanced nor retracted.The physician forcibly removed the device positioning unit (dpu) from the microcatheter and as a result, the coil became stretched and detached from the dpu.There was 2 cm of the coil remaining in the aneurysm and the rest of the stretched portion of the coil was floating freely.The physician then used two additional stryker atlas stents to ¿tack¿ the free-floating coil into the wall of the basilar and proximally into the left vertebral artery.At this point, the procedure ended and the patient was reported as stable.There was no report of patient adverse event associated with the reported issue.The microcoil instructions for use (ifu) cautions the user to not attempt to use the microcoil system as a guidewire if positioning of the microcatheter is lost during microcoil deployment.The ifu also states, ¿if the micrus microcoil system becomes immobile in the infusion microcatheter, apply a gentle push-pull motion to free it.If unsuccessful, remove both microcatheter and microcoil system together as a unit and replace with new devices.¿ the event narrative indicates that the physician applied excessive force while removing the dpu from the microcatheter.Although a definitive conclusion cannot be made, it appears that procedural and handling factors addressed in the ifu may have contributed to the event and resulting damage.The event required implantation of a stent to fix the free-floating coil to the vessel wall.Therefore, the event meets the mdr reporting criteria as a serious injury.The file will be re-reviewed if additional information is received at a later date.

Manufacturer Narrative

Manufacturer¿s ref.No:(b)(4).[conclusion]: the healthcare professional reported that during the stent-assisted coil embolization procedure to treat a recurring (recanalized) 5 mm basilar tip aneurysm that had been previously treated with an enterprise stent (catalog and lot numbers unavailable) through the right posterior communicating artery (pca) with micrus coils (catalog and lot numbers unavailable), the physician determined that a second stent through the left pca was needed and successfully deployed a stryker atlas stent through the sl-10 microcatheter.The sl-10 microcatheter was then exchanged for the prowler select lp microcatheter and accessed the aneurysm.The presidio 10 cere 5 mm x 17 cm coil (b)(4).Was deployed into the aneurysm and during deployment of the coil, the microcatheter purchased into the aneurysm and was lost several times.Each time the microcatheter purchased and lost, the coil was used as a guidewire for the microcatheter to climb over and back into the aneurysm.At one point, with 2 cm of the coil in the aneurysm, the coil became stuck and could not be advanced nor retracted.The physician forcibly removed the device positioning unit (dpu) from the microcatheter and as a result, the coil became stretched and detached from the dpu.There was 2 cm of the coil remaining in the aneurysm and the rest of the stretched portion of the coil was floating freely.The physician then used two additional stryker atlas stents to ¿tack¿ the free-floating coil into the wall of the basilar and proximally into the left vertebral artery.At this point, the procedure ended and the patient was reported as stable.There was no report of patient adverse event associated with the reported issue.The microcoil instructions for use (ifu) cautions the user to not attempt to use the microcoil system as a guidewire if positioning of the microcatheter is lost during microcoil deployment.The ifu also states, ¿if the micrus microcoil system becomes immobile in the infusion microcatheter, apply a gentle push-pull motion to free it.If unsuccessful, remove both microcatheter and microcoil system together as a unit and replace with new devices.¿ the event narrative indicates that the physician applied excessive force while removing the dpu from the microcatheter.Although a definitive conclusion cannot be made, it appears that procedural and handling factors addressed in the ifu may have contributed to the event and resulting damage.The event required implantation of a stent to fix the free-floating coil to the vessel wall.Therefore, the event meets the mdr reporting criteria as a serious injury.The file will be re-reviewed if additional information is received at a later date.Investigation summary: the embolic coil is detached from distal end.The embolic coil was not retuned.Device is fully sheathed with no protrusions.No apparent kinks or bends in the dpu core wire.The embolic coil is mechanically detached.The rh coil has not heated.The v-notch of the sheathing tool is undamaged.Advancement cannot be tested because the embolic coil is not attached.A review of manufacturing documentation associated with this lot (s12089) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no non-conformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.Investigation conclusion: the complaint that the embolic coil stretched cannot be confirmed.The embolic coil was not returned.The complaint that the device was impeded in the delivery catheter cannot be confirmed, also because the embolic coil was not returned.The complaint that the embolic coil protruded into the parent vessel cannot be evaluated based on the condition of the returned device, and so cannot be confirmed.The complaint that the embolic coil detached prematurely is confirmed.The embolic coil is not attached and was not returned, and the rh coil has not heated.According to the event description, the user employed the microcoil system as a guidewire several times when positioning was lost.The ifu (lcn 51844-001 rev.C) cautions against using the device as a guidewire.It is possible that this use error contributed to the reported stretching and detachment of the embolic coil during the procedure.In addition, the user reported that this was a second procedure, and that a stent and micrus coils were previously in place.The event description indicates that 2 cm of the embolic coil entered the existing coil mass and was inhibited from advancing further.It is probable that the existing coil mass and possible existing embolization prevented the new coil from being fully inserted into the aneurysm.Device history lot: a review of manufacturing documentation associated with this lot (s12089) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no non-conformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.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.

• Brand Name: PRESIDIO 10 CERE 5MMX17CM
• Type of Device: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): SEE H.10; 47709 fremont blvd; fremont CA 94538
• MDR Report Key: 7570185
• MDR Text Key: 110113400
• Report Number: 3008114965-2018-00631
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00878528003014
• UDI-Public: 00878528003014
• Combination Product (y/n): N
• PMA/PMN Number: K002056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Catalogue Number: PC410051730
• Device Lot Number: S12089
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2018
• Date Manufacturer Received: 05/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1