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 07/20/2021

Event Type  Injury  

Event Description

It was reported in a literature article submitted from the department of neuroradiology, heidelberg university hospital germany submitted an article about concomitant acute ischemic stroke and upper extremity arterial occlusion: feasibility of mechanical thrombectomy of the upper limb using neuro interventional devices and techniques in germany, published in 20 july 2021.During the craniocervical occlusion case the patient presented with high grade stenosis in the right - sided occlusion of the common carotid artery it was treated with the percutaneous transluminal angioplasty (pta) and stenting of a high-grade stenosis.During craniocervical mechanical thrombectomy procedure a dissection of the cervical vertebral artery (v2-segment), which was treated pharmacologically by the administration of heparin and aspirin.Due to the only minor hemodynamic effects and good flow via the contralateral vertebral artery, no interventional treatment was necessary.No patient clinical consequences were reported.No other information is available about this event.

Manufacturer Narrative

The device is not available to the manufacturer.

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.No visual or functional inspection was performed due to subject retriever device 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.It was reported in a literature article that during the craniocervical mechanical thrombectomy procedure, the patient experienced a dissection of the cervical vertebral artery (v2 segment).Heparin and aspirin was administered to the patient as additional medication.The as 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 in a literature article submitted from the the department of neuroradiology, heidelberg university hospital germany submitted an article about concomitant acute ischemic stroke and upper extremity arterial occlusion: feasibility of mechanical thrombectomy of the upper limb using neurointerventional devices and techniques in germany, published in 20 july 2021.During the craniocervical occlusion case the patient presented with high grade stenosis in the right - sided occlusion of the common carotid artery it was treated with the percutaneous transluminal angioplasty (pta) and stenting of a high-grade stenosis.During craniocervical mechanical thrombectomy procedure a dissection of the cervical vertebral artery (v2-segment), which was treated pharmacologically by the administration of heparin and aspirin.Due to the only minor hemodynamic effects and good flow via the contralateral vertebral artery, no interventional treatment was necessary.No patient clinical consequences were reported.No other information is available about this event.

• 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: 14379596
• MDR Text Key: 291715495
• Report Number: 3012931345-2022-00095
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K132641
• 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: 08/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2022
• 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: 08/10/2022
• 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
• Patient Outcome(s): Other