MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK EXCELSIOR XT-27 STD STRAIGHT 150CM; CATHETER, PERCUTANEOUS

Catalog Number M003XT2750810

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Intracranial Hemorrhage (1891); Paralysis (1997); Paresis (1998); Perforation of Vessels (2135); Brain Injury (2219); Loss of consciousness (2418)

Event Date 12/20/2021

Event Type  Injury  

Manufacturer Narrative

2 of 4 mdrs.The device is not available to the manufacturer.

Event Description

It was reported that during the treatment of a micro- perforation to the m2 of the left mca, physician used the subject microcatheter and guidewires to deploy stent.He re-sheathed the stent and during deployment it was slightly migrated to forward direction while applying forward pressure to delivery system and covered the mca branch.15 minutes post deployment physician noticed contrast leaking distal to the stent indicating vessel perforation.On review of imaging, it was cleared that the perforation happened before stent deployment and after the placement of subject microcatheter and guidewires.It is undeterminable if the devices caused the perforation.Balloon angioplasty was performed to stop bleeding and protamine was administered to reverse heparin.4 hours post procedure patient started bleeding again at m1/m2 bifurcation.Another surgery was performed to remove the blood from brain and the stent was seen protruding from the vessel.It is undeterminable if the stent caused the perforation.Patient suffered paralysis and is currently in icu.No additional information available.

Event Description

It was reported that during the treatment of a micro- perforation to the m2 of the left mca, physician used the subject microcatheter and guidewires to deploy stent.He re-sheathed the stent and during deployment it was slightly migrated to forward direction while applying forward pressure to delivery system and covered the mca branch.15 minutes post deployment physician noticed contrast leaking distal to the stent indicating vessel perforation.On review of imaging, it was cleared that the perforation happened before stent deployment and after the placement of subject microcatheter and guidewires.It is undeterminable if the devices caused the perforation.Balloon angioplasty was performed to stop bleeding and protamine was administered to reverse heparin.4 hours post procedure patient started bleeding again at m1/m2 bifurcation.Another surgery was performed to remove the blood from brain and the stent was seen protruding from the vessel.It is undeterminable if the stent caused the perforation.Patient suffered paralysis and is currently in icu.No additional information available.

Manufacturer Narrative

Due to the automated manufacturing execution system (mes) system there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device was not returned; therefore, physical as well as functional evaluation could not be performed.The reported event is covered in the device directions for use (dfu).The reported 'patient intracranial hemorrhage', ' patient neurological deficit' and 'patient vessel perforation' are documented as potential adverse events associated with the use of microcatheters or with the endovascular procedures, with in the device dfu.An assignable cause of anticipated procedural complication will be assigned to the reported complaint as a product related root cause does not apply and the issue is due to a known physiological effect of the procedure and/or patient condition noted with the directions for use, product labeling and/or risk documentation files.

Manufacturer Narrative

B2: outcomes attributed to ae: added: hospitalization-initial or prolonged and disability or permanent, b5 - executive summary: updated f10: clinical /health signs code grid : paralysis: corrected to paresis loss of consciousness ¿ added f10: health impact code grid : intensive care ¿ added.

Event Description

It was reported that during the treatment of a micro- perforation to the m2 of the left mca, physician used the subject microcatheter and guidewires to deploy stent.He re-sheathed the stent and during deployment it was slightly migrated to forward direction while applying forward pressure to delivery system and covered the mca branch.15 minutes post deployment physician noticed contrast leaking distal to the stent indicating vessel perforation.On review of imaging, it was cleared that the perforation happened before stent deployment and after the placement of subject microcatheter and guidewires.It is undeterminable if the devices caused the perforation.Balloon angioplasty was performed to stop bleeding and protamine was administered to reverse heparin.4 hours post procedure patient started bleeding again at m1/m2 bifurcation.Another surgery was performed to remove the blood from brain and the stent was seen protruding from the vessel.It is undeterminable if the stent caused the perforation.Patient suffered paralysis and is currently in icu.No additional information available.Update: it was reviewed on 04-apr-2022 that during the procedure prior to flow diverter stent implantation, when the guidewire was advanced along with the subject microcatheter, the patient suffered micro-perforation to m2 of left mca (middle cerebral artery) that went un-noticed for approximately 45 minutes as the bleed was very small and was noticed only after 15 min post deployment of flow diverter stent when the contrast leaked into brain.Micro-perforation was quite distal to where the flow diverter was implanted.Protamine was administered to reverse heparin and balloon angioplasty was done to help stop bleeding/patch vessel.Four hours post procedure, patient was moved to neurosurgery to remove blood from brain.Patient was still in icu last heard.Physician says the best outcome for patient is hemiparesis, vegetative state.

• Brand Name: EXCELSIOR XT-27 STD STRAIGHT 150CM
• Type of Device: CATHETER, PERCUTANEOUS
• 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: 13310764
• MDR Text Key: 286656329
• Report Number: 3008881809-2022-00028
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113778
• 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: 05/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: M003XT2750810
• Device Lot Number: 23140475
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2021
• 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: AXS INFINITY LONG SHEATH (STRYKER); AXS VECTA INTERMEDIATE CATHETER (STRYKER); EXCELSIOR SL-10 MICROCATHETER (STRYKER); SELECT CATHETER (PENUMBRA); SURPASS EVOLVE FLOW DIVERTING STENT (STRYKER); SYNCHRO 10 GUIDEWIRE (STRYKER); SYNCHRO 2 GUIDEWIRE (STRYKER); TRANSFORM BALLOON CATHETER (STRYKER)
• Patient Outcome(s): Required Intervention; Other; Disability; Hospitalization
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Race: White