MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK EXCELSIOR SL-10 STRAIGHT 1 TIP 150CM; CATHETER, PERCUTANEOUS

Model Number	M0031681810
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	10/19/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is not available to manufacturer.
Event or Problem Description
It was reported that procedure of thrombectomy for left m1-distal was performed on (b)(6) 2020.The modified rankin scale (mrs) of the patient before the procedure was 2.The alberta stroke program early ct score (aspects) before procedure was 8.The thrombolysis in cerebral infarction (tici) was 0 before procedure.The national institutes of health stroke scale (nihss) score before the procedure was 26.A retriever and aspiration catheter were used to complete the 1st and 2nd passes.However, the modified treatment in cerebral infarction (mtici) was not improved and remained 0 after the 2nd pass.3rd pass was performed using a microcatheter (subject device), stent retriever and a guidewire.Vessel perforation occurred during the 3rd pass; however, the physician could not identify which device caused the perforation.After the procedure, the final tici was 2a and nihss was 30.The mrs score became worse to 4 on (b)(6) 2020 and the mrs score became worse to 5 on (b)(6) 2021.No further information is available.
Event or Problem Description
It was reported that procedure of thrombectomy for left m1-distal was performed on (b)(6) 2020.The modified rankin scale (mrs) of the patient before the procedure was 2.The alberta stroke program early ct score (aspects) before procedure was 8.The thrombolysis in cerebral infarction (tici) was 0 before procedure.The national institutes of health stroke scale (nihss) score before the procedure was 26.A retriever and aspiration catheter were used to complete the 1st and 2nd passes.However, the modified treatment in cerebral infarction (mtici) was not improved and remained 0 after the 2nd pass.3rd pass was performed using a microcatheter (subject device), stent retriever and a guidewire.Vessel perforation occurred during the 3rd pass; however, the physician could not identify which device caused the perforation.After the procedure, the final tici was 2a and nihss was 30.The mrs score became worse to 4 on (b)(6) 2020 and the mrs score became worse to 5 on (b)(6) 2021.No further information is available.
Additional Manufacturer Narrative
Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device is not available; therefore, visual and functional testing as well as physical analysis cannot be performed.The reported event could not be confirmed and it cannot be confirmed that the device met specification when released, as the device was not returned.An assignable cause of anticipated procedural complication will be assigned to this 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.

• Brand Name: EXCELSIOR SL-10 STRAIGHT 1 TIP 150CM
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• MDR Report Key: 11445808
• Report Number: 3008881809-2021-00117
• Device Sequence Number: 3618814
• Product Code: DQY
• UDI-Device Identifier: 04546540688200
• UDI-Public: 04546540688200
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K013789
• 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): 06/29/2021

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 Model Number: M0031681810
• Device Catalogue Number: M0031681810
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/12/2021
• Supplement Date Received by Manufacturer: 06/09/2021
• Initial Report FDA Received Date: 03/09/2021
• Supplement Report FDA Received Date: 06/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ASPIRATION CATHETER (UNKNOWN MANUFACTURER); TRAXCESS GUIDEWIRE (TERUMO); TREVO XP RETRIEVER (STRYKER); TRON FX STENT RETRIEVER (TERUMO); ASPIRATION CATHETER (UNKNOWN MANUFACTURER); TRAXCESS GUIDEWIRE (TERUMO); TREVO XP RETRIEVER (STRYKER); TRON FX STENT RETRIEVER (TERUMO)
• Outcome Attributed to Adverse Event: Other
• Patient Age: 77 YR