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

Catalog Number UNK_NEU

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

Patient Problems Embolus (1830); Vascular Dissection (3160)

Event Date 05/16/2020

Event Type  Injury  

Manufacturer Narrative

This is 2nd of four reports.The subject device is unavailable to manufacturer.

Event Description

It was reported that during study procedure, the embolization to new territory (ent) occurred, therefore; a thrombectomy was performed in response to the patient¿s embolization to new territory.According to the site, the reported event was related to the index stroke, procedure and the subject device (balloon guide catheter).The outcome was resolved, and no adverse consequence reported.

Manufacturer Narrative

Patient code: added dissection 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 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.Information received on 24-june-2020 indicated that the cause of the ent was artery to artery from carotid dissection.Additional information provided by the customer indicated that the physician did not allege any malfunction against the subject device which performed as intended, continuous flush was maintained throughout the procedure, and there was no significant tortuosity noted in the patient's anatomy.The reported 'patient embolus' and 'patient vessel dissection' are known and anticipated complications to these types of procedures and patient condition and are listed as such in the device directions for use.Therefore, an assignable cause of anticipated procedural complication was assigned to this event.This is 2nd of four reports.

Event Description

It was reported that during study procedure, the embolization to new territory (ent) occurred, therefore; a thrombectomy was performed in response to the patient¿s embolization to new territory.According to the site, the reported event was related to the index stroke, procedure and the subject device (balloon guide catheter).The outcome was resolved, and no adverse consequence reported.Update additional information: received additional information on 22-july-2020 indicated that the carotid lesion was already occurred during procedure and was not related to the subject device.

• Brand Name: UNKNOWN_NEUROVASCULAR_PRODUCT
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY; 4870 west 2100 south; salt lake city UT 84120
• MDR Report Key: 10094704
• MDR Text Key: 193425591
• Report Number: 3012931345-2020-00080
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• PMA/PMN Number: K153729
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 08/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2020
• 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
• Date Manufacturer Received: 07/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: EXCELSIOR XT-27 MICROCATHTER (STRYKER); SYNCHRO 2 GUIDEWIRE (STRYKER); TREVO XP PROVUE RETRIEVER 6X25 (STRYKER)
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 45 YR