MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY TREVO PRO 18RO MICROCATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number 90238

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

Patient Problems Infarction, Cerebral (1771); Coma (2417)

Event Date 10/12/2019

Event Type  Injury  

Event Description

It was reported that during the procedure for treating an acute ischemic stroke in the left middle cerebral artery, the stent retriever could not be advanced anymore or withdrawn from inside the subject catheter.The physician withdrew both the stent retriever and subject catheter from inside the patient anatomy as he considered the stent retriever to be damaged.This event resulted in a thirty-minute surgical delay during the procedure and the physician assumed the patient suffered a large area of cerebral infarction and passed into a coma from the surgical delay.There is no direct relationship between the device and the adverse event, but the physician thought that the patient with large area cerebral infarction because of the surgical delay.The procedure was completed successfully with another product.No further information is available.

Manufacturer Narrative

The device history record (dhr) review confirms that the device met all material, assembly and performance specifications.The returned product was confirmed.During visual inspection, the device was inspected and the catheter shaft was found kinked/bent and flat/crushed.No other anomalies were noted.During functional inspection, the retriever was advanced through this catheter with no friction.The reported defect was not confirmed; however the analysis results are consistent with the event.Based on the results of the dhr review, there is no indication that the device, labeling or packaging failed to meet its specifications when released.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 per the additional information, the patient¿s anatomy was moderately tortuous.The device was returned and the catheter was noted to be kinked and flattened.It is probable that the catheter was damaged during advancement due to the tortuous anatomy causing the reported event.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.Therefore, an assignable cause of procedural factors will be assigned to the reported and analyzed event.The reported patient complications and patient stroke are known and anticipated complications 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.

Event Description

It was reported that during the procedure for treating an acute ischemic stroke in the left middle cerebral artery, the stent retriever could not be advanced anymore or withdrawn from inside the subject catheter.The physician withdrew both the stent retriever and subject catheter from inside the patient anatomy as he considered the stent retriever to be damaged.This event resulted in a thirty-minute surgical delay during the procedure and the physician assumed the patient suffered a large area of cerebral infarction and passed into a coma from the surgical delay.There is no direct relationship between the device and the adverse event, but the physician thought that the patient with large area cerebral infarction because of the surgical delay.The procedure was completed successfully with another product.No further information is available.

• Brand Name: TREVO PRO 18RO MICROCATHETER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY; 4870 west 2100 south; salt lake city UT 84120
• MDR Report Key: 9330495
• MDR Text Key: 166636439
• Report Number: 3012931345-2019-00091
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• PMA/PMN Number: K113260
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 01/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/23/2021
• Device Catalogue Number: 90238
• Device Lot Number: 0000022918
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2019
• Date Manufacturer Received: 01/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TREVO PROVUE STENT RETRIEVER (STRYKER); TREVO PROVUE STENT RETRIEVER (STRYKER)
• Patient Outcome(s): Other
• Patient Age: 49 YR
• Patient Weight: 69