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

Model Number	M003XT2750910
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	11/12/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the procedure, the phenom 27 device could not be placed in the landing zone and it was exchanged for an subject excelsior microcatheter for better access.The pipeline was stacked inside and it was not able to release the pipeline in the landing zone.The pipeline was stuck during delivery before the distal coil exited the subject microcatheter.Many attempts were made to push and pull the pipeline and to reposition the subject microcatheter, but without success.The subject microcatheter device was replaced by another manufacturer's device to complete the procedure.Post procedural angiography showed complete occlusion.No patient injury was reported as a results of the event.The patient was undergoing embolization treatment for unruptured fusiform aneurysm measuring 25mmx15mm located in the right internal carotid artery (ica)/c7.The distal and proximal landing zone was 3.00mmx4,50mm.The vasculate was severe in tortuosity.The patient was on dual antiplatelet.The subject microcatheter was flushed with heparinized saline.Physician released load but did not solve problem.No damage noted on the subject catheter or the pushwire.No other information was provided.
Additional Manufacturer Narrative
Gtin: added catalog # search- corrected from 'unknown' to 'm003xt2750910' d1 product long description: corrected to 'excelsior xt-27 std pre-shaped 150cm' c2/d10- concomitant products grid -added.Due to the automated manufacturing execution system (mes) system there are controls in the manufacturing process to ensure the product met specifications upon release.Visual inspection of the device revealed that the catheter shaft was cut and the proximal catheter shaft was found to be heat damage.The functional testing could not be performed due to the condition of the returned device.The reported defect was confirmed based on analysis of the device.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.The reported event is covered in the device direction 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.Additional information indicated the patients anatomy was severely torturous which would have contributed to the event.No patient injury was reported as a results of the event.There were requests for more information, but no more information was received.The catheter shaft was found badly damaged, and the catheter shaft appeared to be cut.The issue is associated with a product that meets stryker design and manufacture specifications and was used in according with the dfu but due to procedural and anatomical factors during use, the product performance was limited.The as reported as well as the listed in the grid below will be assigned procedural factors.
Event or Problem Description
It was reported that during the procedure, the phenom 27 device could not be placed in the landing zone and it was exchanged for an subject excelsior microcatheter for better access.The pipeline was stacked inside and it was not able to release the pipeline in the landing zone.The pipeline was stuck during delivery before the distal coil exited the subject microcatheter.Many attempts were made to push and pull the pipeline and to reposition the subject microcatheter, but without success.The subject microcatheter device was replaced by another manufacturer's device to complete the procedure.Post procedural angiography showed complete occlusion.No patient injury was reported as a results of the event.The patient was undergoing embolization treatment for unruptured fusiform aneurysm measuring 25mmx15mm located in the right internal carotid artery (ica)/c7.The distal and proximal landing zone was 3.00mmx4,50mm.The vasculate was severe in tortuosity.The patient was on dual antiplatelet.The subject microcatheter was flushed with heparinized saline.Physician released load but did not solve problem.No damage noted on the subject catheter or the pushwire.No other information was provided.

• Brand Name: EXCELSIOR XT-27 STD PRE-SHAPED 150CM
• Common Device Name: 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: 15031172
• Report Number: 3008881809-2022-00349
• Device Sequence Number: 17276733
• Product Code: DQY
• UDI-Device Identifier: 04546540698155
• UDI-Public: 04546540698155
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K113778
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/05/2022
• Device Model Number: M003XT2750910
• Device Catalogue Number: M003XT2750910
• Device Lot Number: 21298175
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/07/2022
• Supplement Date Received by Manufacturer: 10/14/2022
• Initial Report FDA Received Date: 07/15/2022
• Supplement Report FDA Received Date: 10/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PHENOM 27 DEVICE (UNKNOWN MANUFACTURER); PIPELINE DEVICE (UNKNOWN MANUFACTURER)
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown