MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY TREVO PROVUE 4MM X 20MM; CATHETER, THROMBUS RETRIEVER

Model Number	90184
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	07/17/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during mca (middle cerebral artery) m1 bifuration thrombus case, delivered guiding catheter to c2 and then used guidewire to bring pr-18 catheter to pass the thrombus to m2 segment and delivered cat6 guiding catheter to m1 to near the thrombus.During delivery of the stent the operator felt resistance inside the catheter, withdrew the stent and found the insertion tool damaged, so replaced it with another stent to do thrombectomy.After this stent (subject device) was deployed to catch the thrombus and retracted out, the vessel deformed severely (the shape of the vessel changed).So the operator placed the cat6 to near the proximal of stent and used pr-18 to take the stent out and used cat6 to do aspiration successfully.The procedure was completed successfully.
Event or Problem Description
It was reported that during mca (middle cerebral artery) m1 bifuration thrombus case, delivered guiding catheter to c2 and then used guidewire to bring pr-18 catheter to pass the thrombus to m2 segment and delivered cat6 guiding catheter to m1 to near the thrombus.During delivery of the stent the operator felt resistance inside the catheter, withdrew the stent and found the insertion tool damaged, so replaced it with another stent to do thrombectomy.After this stent (subject device) was deployed to catch the thrombus and retracted out, the vessel deformed severely (the shape of the vessel changed).So the operator placed the cat6 to near the proximal of stent and used pr-18 to take the stent out and used cat6 to do aspiration successfully.The procedure was completed successfully.
Additional 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 retriever coils were seen to be damaged, the retriever shaped section was seen to have procedural fluid present, the retriever shaped section was intact and the insertion tool was not returned.A functional test was not required.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 unable to be confirmed as the reported defect is patient harm.The device did not met specification when returned for investigation, as seen by the returned damaged retriever coils.Based upon medical review, the harm observed in the complaint is anticipated in nature as per the device risk assessment.The device was returned and retriever coils damage were noted.An assignable cause of anticipated procedural complication will be assigned to the reported 'patient injury' 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.An assignable cause of procedural factors will be assigned to the analyzed 'retriever coils damaged', as 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/or anatomical factors during use, the product performance was limited.

• Brand Name: TREVO PROVUE 4MM X 20MM
• Common Device Name: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY; 4870 west 2100 south; salt lake city UT 84120
• Manufacturer (Section G): STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY; 4870 west 2100 south; salt lake city UT 84120
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 15205326
• Report Number: 3012931345-2022-00156
• Device Sequence Number: 19363913
• Product Code: NRY
• UDI-Device Identifier: 00815742001846
• UDI-Public: 00815742001846
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K120961
• 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): 10/18/2022

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: 06/28/2023
• Device Model Number: 90184
• Device Catalogue Number: 90184
• Device Lot Number: 0000066653
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/27/2022
• Supplement Date Received by Manufacturer: 10/11/2022
• Initial Report FDA Received Date: 08/10/2022
• Supplement Report FDA Received Date: 10/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/29/2021
• 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: 8F GUIDING CATHETER (STRYKER); CAT 6 CATHETER (STRYKER); PRO-18 CATHETER (NON- STRYKER); TREVO PROVUE RETRIEVER (STRYKER)
• Outcome Attributed to Adverse Event: Other
• Patient Age: 76 YR
• Patient Sex: Unknown
• Patient Weight: 65 KG
• Patient Race: Asian