MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 8MM X 20CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number M0035478200

Device Problems Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stroke/CVA (1770); Hernia (2240); Embolism/Embolus (4438); Thrombosis/Thrombus (4440)

Event Date 09/03/2022

Event Type  Death  

Event Description

It was reported that during ruptured aneurysm, when physician tried to reposition the subject coil, it was stuck in the catheter and did not move at all.Physician tried to retract the subject coil but was unsuccessful, so used a snail and a stent retriever as a medical intervention.When removed the subject coil found that the last loop was hooked in another hoop, and it was stretched completely.There was a surgical delay of 5 hours.As a result, the patient had a big stroke on the left side.The patient has another aneurysm on the other side that initially wanted to treat at the same time, but it could not be treated.Physician decided to proceed in the coming days.Patient current status is unknown.No other information is available.

Manufacturer Narrative

The device is not available to the manufacturer.

Manufacturer Narrative

Due to the automated mes (manufacturing execution system) system there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the main coil was seen to be kinked/bend, stretched, and tangled, the main coil was seen to be broken/fractured, the delivery wire was not returned, and the coil introducer sheath was not returned.A functional test could not be carried out due to the severe coil damage.The reported event is covered in the device directions for use (dfu).As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.The reported event was confirmed; the analysis results are consistent with the reported event.The device failed to meet specifications when received for complaint investigation based on the analysed anomalies noted to the device.The information provided states that the physician determined that the patient complications were due to a device malfunction.The partially placed coil started to unwind after 1st repositioning.The returned device was analysed, and the results are consistent with the reported event.The main coil was found to be heavily damaged and functional/dimensional inspection could not be completed.The coil delivery wire was not returned.This complaint appears to be associated with a product that met stryker design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural factors during use.Therefore, an assignable cause of procedural factors will be assigned to all as reported 'coil in catheter friction', 'coil jammed', 'main coil stretched', 'main coil tangled', 'main coil broken fractured during use', 'patient stroke', 'patient vessel thrombosis', 'patient embolus', 'patient death', 'patient complications' and to as analysed codes 'main coil stretched', 'main coil tangled', 'main coil broken fractured during use', and ¿main coil kinked/bent¿.

Event Description

It was reported that during ruptured aneurysm, when physician tried to reposition the subject coil, it was stuck in the catheter and did not move at all.Physician tried to retract the subject coil but was unsuccessful, so used a snail and a stent retriever as a medical intervention.When removed the subject coil found that the last loop was hooked in another hoop, and it was stretched completely.There was a surgical delay of 5 hours.As a result, the patient had a big stroke on the left side.The patient has another aneurysm on the other side that initially wanted to treat at the same time, but it could not be treated.Physician decided to proceed in the coming days.Patient current status is unknown.No other information is available.Additional information received on 22 sep 2022, it was reported that after repositioning the first subject coil in an aneurysm in the left pcom artery, the coil was stuck in the microcatheter and was not retrievable or pushable.While attempting to pull back, the subject coil started to unwind within the microcatheter, and the first loop formed knot inside aneurysm.A thrombus formed around the subject coil in internal carotid artery (ica).The microcatheter tip stayed within the aneurysm during deployment and retrieval.Several maneuvers were undertaken to retrieve subject coil and microcatheter.The microcatheter had to be cut several times with the partially deployed subject coil to be retrieved by microsnare.There were further unwinding of the subject coil within the microcatheter causing occlusion of the microcatheter and fracturing of residual subject coil.The final subject coil residue together with big clot/thrombus were eventually recovered with a stent retriever.During attempts to remove proximal clot and distal emboli with stent retriever, there was a perforation and recurrent embolization occurred.There were 5 hours delay.The outcome was a stroke (mtici score of 2a) and the aneurysm was thrombosed.The patient underwent hemicraniectomy.There was brain herniation and patient deceased.The relationship of patient death to the coil (subject device) and the associated procedure is unknown.No other information is available.Additional information received on 06 oct 2022, the relationship of patient death to the coil(subject device) and the associated procedure was related to the coil(subject device).Patient passed away on (b)(6) 2022.It was also confirmed that vessel perforation is not related to the coil (subject device).Total of 9000 iu heparin during procedure was given to patient.5000 iu at start and 1000 /h.After perforation this medication was discontinued.Eptifibatide started after full retrieval of subject coil.This was given as intraarterial bolus 7.9ml of (2mg/ml), i.V.14ml/h (of 0.75mg/ml) and was discontinued 4h after end of procedure.

Event Description

It was reported that during ruptured aneurysm, when physician tried to reposition the subject coil, it was stuck in the catheter and did not move at all.Physician tried to retract the subject coil but was unsuccessful, so used a snail and a stent retriever as a medical intervention.When removed the subject coil found that the last loop was hooked in another hoop, and it was stretched completely.There was a surgical delay of 5 hours.As a result, the patient had a big stroke on the left side.The patient has another aneurysm on the other side that initially wanted to treat at the same time, but it could not be treated.Physician decided to proceed in the coming days.Patient current status is unknown.No other information is available.Additional information received on 22 sep 2022, it was reported that after repositioning the first subject coil in an aneurysm in the left pcom artery, the coil was stuck in the microcatheter and was not retrievable or pushable.While attempting to pull back, the subject coil started to unwind within the microcatheter, and the first loop formed knot inside aneurysm.A thrombus formed around the subject coil in internal carotid artery (ica).The microcatheter tip stayed within the aneurysm during deployment and retrieval.Several maneuvers were undertaken to retrieve subject coil and microcatheter.The microcatheter had to be cut several times with the partially deployed subject coil to be retrieved by microsnare.There were further unwinding of the subject coil within the microcatheter causing occlusion of the microcatheter and fracturing of residual subject coil.The final subject coil residue together with big clot/thrombus were eventually recovered with a stent retriever.During attempts to remove proximal clot and distal emboli with stent retriever, there was a perforation and recurrent embolization occurred.There were 5 hours delay.The outcome was a stroke (mtici score of 2a) and the aneurysm was thrombosed.The patient underwent hemicraniectomy.There was brain herniation and patient deceased.The relationship of patient death to the coil (subject device) and the associated procedure is unknown.No other information is available.Additional information received on 06 oct 2022, the relationship of patient death to the coil(subject device) and the associated procedure was related to the coil(subject device).Patient passed away on (b)(6) 2022.It was also confirmed that vessel perforation is not related to the coil (subject device).Total of 9000 iu heparin during procedure was given to patient.5000 iu at start and 1000 /h.After perforation this medication was discontinued.Eptifibatide started after full retrieval of subject coil.This was given as intraarterial bolus 7.9ml of (2mg/ml), i.V.14ml/h (of 0.75mg/ml) and was discontinued 4h after end of procedure.

Manufacturer Narrative

This is 1/3 emdr reports.A2 age at time of event - added.B1 adverse event/product problem: updated.B2 outcome attributed to ae: added event death.B2 death date: added.B5 executive summary: updated.C2/d10 concomitant products grid: updated.H1 type of reportable event: updated.F10 / h6 health effect - clinical code: updated.F10 / h6 health effect - impact code: updated.F10 / h6 medical device problem code: updated.

• Brand Name: TARGET 360 SOFT 8MM X 20CM
• Type of Device: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer (Section G): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 15439906
• MDR Text Key: 300068672
• Report Number: 3008881809-2022-00455
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 04546540676597
• UDI-Public: 04546540676597
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K153658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/13/2022

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
• Device Operator: Health Professional
• Device Model Number: M0035478200
• Device Catalogue Number: M0035478200
• Device Lot Number: 23061617
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/05/2022
• Initial Date FDA Received: 09/16/2022
• Supplement Dates Manufacturer Received: 09/22/2022; 12/01/2022
• Supplement Dates FDA Received: 10/18/2022; 12/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/29/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: BENCHMARK CATHETER(NON-STRYKER); GUIDING CATHETER(UNKNOWN); SCEPTER BALLOON(NON-STRYKER); SOLITAIR STENT RETRIEVER(NON-STRYKER); STENT RETRIEVER (NON-STRYKER); STENT RETRIEVER (NON-STRYKER); SYNCHRO GUIDEWIRE(STRYKER); XT-17 MICROCATHETER (STRYKER); XT-17 MICROCATHETER(STRYKER)
• Patient Outcome(s): Other; Death; Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female