MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TRANSFORM SUPER COMPLIANT 3MM X 5MM - US; CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY

Model Number	M003SSC03050
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Stroke/CVA (1770); Paresis (1998)
Date of Event	09/23/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is not available to manufacturer.
Event or Problem Description
It was reported that during a clinical trial, a flow diverter was used for treatment.The subject balloon was also used for in stent balloon angioplasty in a small area of non-apposition of the proximal end of the flow diverter.Excellent apposition was achieved and the procedure was completed successfully.Post procedure, the patient had a stroke that presented as right hemiparesis.Imaging done showed development of an ill defined acute to early sub acute infarct centered along the posterior limb left internal capsule.Patient was then started on integrillin infusion, taken to icu and phenylephrine was then initiated.Patient was in icu for approximately 5 days.In the physician's opinion, the event had a causal relationship to dual antiplatelet therapy, subject device, other stryker device and underlying condition or disease.Event was reported as recovering/resolving.No other information is available.
Event or Problem Description
It was reported that during a clinical trial, a flow diverter was used for treatment.The subject balloon was also used for in stent balloon angioplasty in a small area of non-apposition of the proximal end of the flow diverter.Excellent apposition was achieved and the procedure was completed successfully.Post procedure, the patient had a stroke that presented as right hemiparesis.Imaging done showed development of an ill defined acute to early sub acute infarct centered along the posterior limb left internal capsule.Patient was then started on integrillin infusion, taken to icu and phenylephrine was then initiated.Patient was in icu for approximately 5 days.In the physician's opinion, the event had a causal relationship to dual antiplatelet therapy, subject device, other stryker device and underlying condition or disease.Event was reported as recovering/resolving.No other 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 reported complaint could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product was not returned.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.Based upon medical review, the harm observed in this complaint is anticipated in nature as per the device risk assessment.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 within the dfu, product labeling and/or risk documentation files, an assignable cause of anticipated procedural complication will be assigned to this complaint.

• Brand Name: TRANSFORM SUPER COMPLIANT 3MM X 5MM - US
• Common Device Name: CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY
• 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: 12669761
• Report Number: 3008881809-2021-00445
• Device Sequence Number: 4298521
• Product Code: MJN
• UDI-Device Identifier: 07613327004717
• UDI-Public: 07613327004717
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K122576
• 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): 02/03/2022

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: 03/29/2022
• Device Model Number: M003SSC03050
• Device Catalogue Number: M003SSC03050
• Device Lot Number: 22219476
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/28/2021
• Supplement Date Received by Manufacturer: 01/07/2022
• Initial Report FDA Received Date: 10/20/2021
• Supplement Report FDA Received Date: 02/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2020
• 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: SURPASS EVOLVE FLOW DIVERTER (STRYKER); SURPASS EVOLVE FLOW DIVERTER (STRYKER)
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Other
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 120 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White