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 Perforation (2001); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/15/2021

Event Type  Injury  

Event Description

It was reported that during the second treatment strategy from a thrombectomy procedure, the patient suffered from a perforation / rupture of the vessel which was treated with the endovascular treatment and required hospitalization.It is noted that the adverse event (perforation / rupture of the vessel) was related to the thrombectomy procedure and the subject study retriever device, not related to the stroke (disease under study) and to an underlying condition or disease.The outcome of the adverse event was resolved without clinical sequalae.No further information is available.

Manufacturer Narrative

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

Event Description

It was reported that during the second treatment strategy from a thrombectomy procedure, the patient suffered from a perforation/rupture of the vessel which was treated with the endovascular treatment and required hospitalization.It is noted that the adverse event (perforation/rupture of the vessel) was related to the thrombectomy procedure and the subject study retriever device, not related to the stroke (disease under study) and to an underlying condition or disease.The outcome of the adverse event was resolved without clinical sequelae.No further information is available.Updated: further reviewing from medical safety team indicated that the lot # 41755664 captured in the reported event does not refer 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 14-august-2023.The manufacturer has reviewed all information and determined this event no longer meets the requirement.

Manufacturer Narrative

B1 adverse event ¿ corrected ¿ no adverse event.B2 outcomes attributed to ae ¿ corrected ¿ no 'hospitalization-initial or prolonged,' ¿other serious (important medical events)¿, and 'required intervention to prevent permanent impairment/damage (devices)'.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: corrected.Although the lot number was not provided, there are controls in the manufacturing process to ensure the product trevo 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.Further reviewing from medical safety team indicated that the lot # 41755664 captured in the reported event does not refer 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 14-august-2023.An assignable cause of undeterminable will be assigned to this complaint.The manufacturer has reviewed all information and determined this event no longer meets the requirement.

Event Description

It was reported that during the second treatment strategy from a thrombectomy procedure, the patient suffered from a perforation/rupture of the vessel which was treated with the endovascular treatment and required hospitalization.It is noted that the adverse event (perforation/rupture of the vessel) was related to the thrombectomy procedure and the subject study retriever device, not related to the stroke (disease under study) and to an underlying condition or disease.The outcome of the adverse event was resolved without clinical sequalae.No further information is available.

Manufacturer Narrative

Although the dhr 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.It was reported that there was a perforation/rupture of the vessel during the procedure.There was no additional information made available.As the device was not returned for analysis, it cannot be confirmed if the device may have caused or contributed to the reported event.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 anticipated procedural complication will be assigned to this complaint.

• 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: 17310607
• MDR Text Key: 319013534
• Report Number: 3012931345-2023-00158
• 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

• Date FDA Received: 07/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_NEU
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/14/2023
• 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 6F DEVICE (STRYKER)
• Patient Outcome(s): Required Intervention; Other; Hospitalization