MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM 3 EZ 2.5MM X 20MM - CE; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number M003EN3E25200

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/06/2020

Event Type  malfunction  

Manufacturer Narrative

Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.The device was received and the reported lot number was confirmed from the packaging label.On visual inspection, the stent delivery wire was broken/fractured.In the event description it states the stent deployed in the hub of the catheter.Functional inspection was not carried out as the stent 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.The stent delivery wire was broken fractured and the stent was not returned.The as reported event can be confirmed based on the analysis and the as reported as well as the as analysed events listed in the complaint code grid will be assigned procedural factors as this complaint appears to be associated with a product that met stryker and design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural factors during use.

Event Description

It was reported that during an aneurysm embolization case, resistance was encountered while advancing the subject stent into the micro catheter hub.The subject stent was retracted and it deployed prematurely in the micro catheter hub.The physician decided to complete the procedure using only coils due to condition of the patient and the length of surgery.Four to five hours post procedure, the patient developed hemorrhage from aneurysm rupture and passed away.Physician confirmed patient death was not due to stryker device.The subject stent was returned for analysis and it was discovered that the stent delivery wire was broken/fractured during use.

• Brand Name: NEUROFORM 3 EZ 2.5MM X 20MM - CE
• Type of Device: STENT, INTRACRANIAL NEUROVASCULAR
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; IE NA
• Manufacturer (Section G): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; IE NA
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 10469171
• MDR Text Key: 205020637
• Report Number: 3008881809-2020-00248
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: CN
• PMA/PMN Number: H020002/S046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/21/2022
• Device Catalogue Number: M003EN3E25200
• Device Lot Number: 21464215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/04/2020
• Initial Date FDA Received: 08/28/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/23/2019
• 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 Age: 55 YR
• Patient Weight: 70