MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK UNKNOWN_NEUROVASCULAR_PRODUCT; CATHETER, PERCUTANEOUS

Catalog Number UNK_NEU

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

Patient Problem Vasoconstriction (2126)

Event Date 11/06/2020

Event Type  Injury  

Event Description

It was reported between the end of procedure and the 1 day post procedure follow-up on the (b)(6) 2020, the patient suffered from a spasm.It was reported there was a possible relationship between the adverse event and the subject catheter device used in the procedure.It was reported the stroke (disease under study) and the thrombectomy procedure were related to the adverse event.The event resolved without clinical sequelae on (b)(6) 2020.No further information is available.

Manufacturer Narrative

H3 other text : the device is not available to the manufacturer.

Event Description

It was reported between the end of procedure and the 1 day post procedure follow-up on the (b)(6) 2020, the patient suffered from a spasm.It was reported there was a possible relationship between the adverse event and the subject catheter device used in the procedure.It was reported the stroke (disease under study) and the thrombectomy procedure were related to the adverse event.The event resolved without clinical sequalae on (b)(6) 2020.No further information is available.Upon further review, it was clarified that the post procedure spasm with possible relation to the subject catheter resolved without clinical sequelae and there was no medical intervention required.There was no malfunction or allegation against the subject catheter.Based on this information, this event does not meet reporting criteria anymore.The event is deemed non reportable.

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 is not available; therefore, visual and functional testing as well as physical analysis cannot 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.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 the reported event of patient vasospasm non-serious.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, PERCUTANEOUS
• 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: 17410352
• MDR Text Key: 319917282
• Report Number: 3008881809-2023-00389
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K151667
• 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: 09/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2023
• 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: 09/08/2023
• 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: SOLITAIRE 6*30 (MEDTRONIC)
• Patient Outcome(s): Other