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 Stroke/CVA (1770); Intracranial Hemorrhage (1891); Perforation (2001); Vasoconstriction (2126); Vascular Dissection (3160); Ruptured Aneurysm (4436)

Event Date 06/30/2021

Event Type  Injury  

Manufacturer Narrative

This is 4/13 emdr reports.The device is not available to the manufacturer.

Event Description

In a retrospective multicenter observational cohort study, conducted to determine safety and efficacy of the surpass streamline (ss) for intracranial aneurysms treatment (a population of cases with predominantly wide-necked small and medium-sized aneurysms).A total of 277 patients with 314 aneurysms were treated between january 2018 and june 2021.3 cases had vessel dissection intraprocedural (cases were asymptomatic), 2 cases had reported vessel spasm intraprocedural (cases were asymptomatic) and 1 case had vessel perforation intraprocedural.7 cases had major ipsilateral ischemic stroke within 6 months, 15 cases had minor ipsilateral ischemic stroke within 6 months and 3 cases had target aneurysm rupture/sah within 6 months.After 6 months to 12 months follow up 8 cases had target aneurysm retreatment.No further information is available.There is no definitive evidence in the article to conclude or deny that the adverse events were related to the subject device.It was not possible to ascertain specific device or patient information from the article, or to match the events reported with previously reported complaints, if any.Therefore, this report addresses all events of vessel dissection, vessel spasm, vessel perforation, major and minor ipsilateral ischemic stroke, target aneurysm rupture/sah and target aneurysm retreatment covered within this literature source.

Manufacturer Narrative

This is 4/13 emdr reports.B5 executive summary: updated.F10 / h6 - clinical signs code grid: updated.F10 / h6 - health impact code grid: updated.Although the dhr(device history record) 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 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.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 as reported event of 'patient vessel dissection¿, ¿patient vasospasm serious¿, ¿patient vessel perforation¿, ¿patient stroke¿ and ¿patient intracranial hemorrhage¿.

Event Description

In a retrospective multicenter observational cohort study, conducted to determine safety and efficacy of the surpass streamline (ss) for intracranial aneurysms treatment (a population of cases with predominantly wide-necked small and medium-sized aneurysms).A total of 277 patients with 314 aneurysms were treated between (b)(6) 2018 and (b)(6) 2021.3 cases had vessel dissection intraprocedural (cases were asymptomatic), 2 cases had reported vessel spasm intraprocedural (cases were asymptomatic) and 1 case had vessel perforation intraprocedural.7 cases had major ipsilateral ischemic stroke within 6 months, 15 cases had minor ipsilateral ischemic stroke within 6 months and 3 cases had target aneurysm rupture/sah within 6 months.After 6 months to 12 months follow up 8 cases had target aneurysm retreatment.No further information is available.There is no definitive evidence in the article to conclude or deny that the adverse events were related to the subject device.It was not possible to ascertain specific device or patient information from the article, or to match the events reported with previously reported complaints, if any.Therefore, this report addresses all events of vessel dissection, vessel spasm, vessel perforation, major and minor ipsilateral ischemic stroke, target aneurysm rupture/sah and target aneurysm retreatment covered within this literature source.23 nov 2022 ¿ after further review of the article, it is clear that the subject device (intermediate catheter) will not reach the target lesion to cause aneurysm rupture.Hence this report will not address the issue of aneurysm rupture that was captured in the initial report.

• 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: 15565359
• MDR Text Key: 301381597
• Report Number: 3008853977-2022-00051
• 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: Other,Literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: No
• Initial Date Manufacturer Received: 09/12/2022
• Initial Date FDA Received: 10/07/2022
• Supplement Dates Manufacturer Received: 11/21/2022
• Supplement Dates FDA Received: 12/06/2022
• 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: AXS CAT 5 CATHETER(STRYKER); AXS OFFSET CATHETER(STRYKER); INFINITY LONG PLUS AXS LS(STRYKER); SURPASS STREAMLINE STENT(STRYKER); SYNCHRO 2 GUIDEWIRE(STRYKER)
• Patient Outcome(s): Other