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

Catalog Number UNK_NEU

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Vascular Dissection (3160)

Event Date 02/02/2021

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 that between end of procedure and 1 day post procedure follow-up from a thrombectomy procedure on (b)(6) 2021, the patient experienced a dissection.It is noted that the adverse event has possibly relationship to the subject study retriever device, thrombectomy procedure, stroke (disease under study) and to an underlying condition.The outcome of the adverse event was resolved with clinical sequalae.No further information is available.

Manufacturer Narrative

Although the dhr (device history record 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.The reported ¿patient vessel dissection¿ is a known and anticipated complication to these types of procedures and patient condition and is listed as such in the device directions for use.Therefore, a probable cause of anticipated procedural complication was assigned to this event.

Event Description

It was reported that between end of procedure and 1 day post procedure follow-up from a thrombectomy procedure on (b)(6) 2021, the patient experienced a dissection.It is noted that the adverse event has possibly relationship to the subject study retriever device, thrombectomy procedure, stroke (disease under study) and to an underlying condition.The outcome of the adverse event was resolved with clinical sequelae.No further information is available.

• 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: 17076513
• MDR Text Key: 316662889
• Report Number: 3012931345-2023-00125
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K120961
• 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
• Report Date: 08/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2023
• 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
• Date Manufacturer Received: 07/26/2023
• 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 (STRYKER).
• Patient Outcome(s): Other