MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-CALIF UNKNOWN_NEUROVASCULAR_PRODUCT; CATHETER, THROMBUS RETRIEVER

Catalog Number UNK_NEU

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

Patient Problems Burn(s) (1757); Hematoma (1884); Hemorrhage/Bleeding (1888); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Perforation (2001); Pseudoaneurysm (2605); Vascular Dissection (3160); Embolism/Embolus (4438)

Event Date 11/20/2023

Event Type  Injury  

Event Description

The survey conducted in spain.Results from the survey stated that adverse events (access site complications ((groin hematoma, retroperitoneal hemorrhage, inflammation, tissue necrosis)), allergic reaction, distal embolization, infection, neurological deficits, parenchymal hematoma, risks associated with angiographic and fluoroscopic radiation ((including but not limited to alopecia, burns ranging in severity from skin reddening to ulcers, cataracts, and delayed neoplasia)), and vessel injury ((perforation, dissection, rupture, pseudoaneurysm)) were reported.No other information was provided.

Manufacturer Narrative

This is 3 of 7 reports (3rd mdr).H3 other text : the device is not available for evaluation.

Manufacturer Narrative

This is 3 of 7 reports (3rd mdr).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 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 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.It was reported that a post-market clinical follow-up (pmcf) survey was conducted for axs vecta 71, (device number unknown, quantity 31) and axs vecta 74 (device number unknown, quantity 11) and responses (double blinded) from physicians was received on (b)(6) 2023.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 "vascular access site complications serious", "patient allergic reaction", "patient infection", "patient neurological deficit", "patient complications", "patient vessel perforation", "patient vessel dissection", "patient pseudoaneurysm", "patient embolus" and "patient hematoma".

Event Description

The survey conducted in spain.Results from the survey stated that adverse events (access site complications ((groin hematoma, retroperitoneal hemorrhage, inflammation, tissue necrosis)), allergic reaction, distal embolization, infection, neurological deficits, parenchymal hematoma, risks associated with angiographic and fluoroscopic radiation ((including but not limited to alopecia, burns ranging in severity from skin reddening to ulcers, cataracts, and delayed neoplasia)), and vessel injury ((perforation, dissection, rupture, pseudoaneurysm)) were reported.No other information was provided.

• Brand Name: UNKNOWN_NEUROVASCULAR_PRODUCT
• Type of Device: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): STRYKER NEUROVASCULAR-CALIF; 47900 bayside parkway; fremont CA 94538
• Manufacturer (Section G): STRYKER NEUROVASCULAR-CALIF; 47900 bayside parkway; fremont CA 94538
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 18231143
• MDR Text Key: 329281123
• Report Number: 3008853977-2023-00046
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172167
• 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: 02/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2023
• 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: 02/07/2024
• 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
• Patient Outcome(s): Other