MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY UNKNOWN_NEUROVASCULAR_PRODUCT; CATHETER, THROMBUS RETRIEVER

Catalog Number UNK_NEU

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Anemia (1706); Hematoma (1884); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/25/2021

Event Type  Injury  

Manufacturer Narrative

This is 1 of 2 reports.H3 other text : the subject device is unavailable to manufacturer.

Event Description

It was reported during a thrombectomy procedure on (b)(6) 2021, there was an hematoma at the puncture site causing hemoglobin levels to fall.It is noted that the adverse event has possibly relationship the subject study device retriever, to the thrombectomy procedure, not related to stroke (disease under study) and to an underlying condition.The outcome of the adverse event was resolved without clinical sequalae.No further information is available.

Manufacturer Narrative

Although the dhr (device history review) could not be reviewed because the lot number remains unknown, there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device was not available; therefore, a visual inspection as well as a functional evaluation could not be performed.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.

Event Description

It was reported during a thrombectomy procedure on (b)(6) 2021, there was an hematoma at the puncture site causing hemoglobin levels to fall.It is noted that the adverse event has possibly relationship the subject study device retriever, to the thrombectomy procedure, not related to stroke (disease under study) and to an underlying condition.The outcome of the adverse event was resolved without clinical sequelae.No further information is available.

Manufacturer Narrative

B1 adverse event ¿ corrected ¿ no adverse event.B2 outcomes attributed to ae ¿ corrected ¿ no ¿other serious (important medical events).¿ b5 executive summary - updated.H1 type of reportable event: no serious injury.F10/h6 device code grid/ clinical signs code grid / health impact code grid: corrected.H6 method code grid/ results code grid/ conclusion code grid: removed.Further reviewing from medical safety team indicated that the hematoma at the puncture site is most probably related to access site device not to the subject trevo device as the event did not contain product performance issues or adverse event associate with subject trevo device performance.Therefore, based on this review, this event does not meet reporting criteria anymore for the corresponding device and the reportability will be changed from reportable to non-reportable with new awareness date of (b)(6) 2023.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.

Event Description

It was reported during a thrombectomy procedure on (b)(6) 2021, there was an hematoma at the puncture site causing hemoglobin levels to fall.It is noted that the adverse event has possibly relationship the subject study device retriever, to the thrombectomy procedure, not related to stroke (disease under study) and to an underlying condition.The outcome of the adverse event was resolved without clinical sequalae.No further information is available.Updated: further reviewing from medical safety team indicated that the hematoma at the puncture site is most probably related to access site device not to the subject trevo device as the event did not contain product performance issues or adverse event associate with subject trevo device performance.Therefore, based on this review, this event does not meet reporting criteria anymore for the corresponding device and the reportability will be changed from reportable to non-reportable with new awareness date of (b)(6) 2023.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.

• Brand Name: UNKNOWN_NEUROVASCULAR_PRODUCT
• Type of Device: 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: 17082884
• MDR Text Key: 316729247
• Report Number: 3012931345-2023-00130
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K150616
• 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: 09/12/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: UNK_NEU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/30/2023
• Initial Date FDA Received: 06/07/2023
• Supplement Dates Manufacturer Received: 07/12/2023; 08/14/2023
• Supplement Dates FDA Received: 07/21/2023; 09/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: CATALYST 5F (STRYKER)
• Patient Outcome(s): Other