MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY TREVO XP PROVUE 3MM X 20MM; CATHETER, THROMBUS RETRIEVER

Catalog Number 90183

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Hemorrhage/Bleeding (1888); High Blood Pressure/ Hypertension (1908); Paralysis (1997); Pneumonia (2011); Dysphasia (2195); Loss of consciousness (2418); Ischemia Stroke (4418); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/19/2021

Event Type  Injury  

Manufacturer Narrative

Device evaluated by mfr: the subject device is unavailable to manufacturer.

Event Description

It was reported that the patient with no specified medical history, had been received the experimental procedure (mechanical thrombectomy) on (b)(6) 2021 (randomization in experimental arm).On (b)(6) 2021, the patient experienced a neurological status deterioration: malignant sylvian infarction (edema and mass effect on early post-thrombectomy ct scan) associated with impaired alertness.) and a craniectomy was performed to treat the event.The patient experienced a life-threatening event.The patient was recovering from neurological status deterioration and was discharged to continuing care.No other information was provided.

Manufacturer Narrative

Section b5 - executive summary: update.Section d- lot # :corrected - lot # has been corrected from unknown to 40362971.Section f10/h6 clinical signs code grid: updated - hemorrhage/bleeding has been added.

Event Description

It was reported that the patient with no specified medical history, had been received the experimental procedure (mechanical thrombectomy) on (b)(6) 2021 (randomization in experimental arm).On (b)(6) 2021, the patient experienced a neurological status deterioration: malignant sylvian infarction (edema and mass effect on early post-thrombectomy ct scan) associated with impaired alertness.) and a craniectomy was performed to treat the event.The patient experienced a life-threatening event.The patient was recovering from neurological status deterioration and was discharged to continuing care.No other information was provided.Update information: received additional information on 27-december-2021 stated that at the patient's 3-month follow-up, a blinded assessment of the mrs (modified rankin score) was performed by telephone on (b)(6) 2021.The current mrs is 3.Per physician¿s opinion, the subject trevo device performed as intended and there was no allegation against the subject trevo device.

Manufacturer Narrative

Section f10/h6 clinical signs code grid: corrected - ischemia stroke and high blood pressure/ hypertension have been removed.Added: paralysis , dysphasia, and pneumonia.

Event Description

It was reported that the patient with no specified medical history, had been received the experimental procedure (mechanical thrombectomy) on (b)(6) 2021 (randomization in experimental arm).On (b)(6) 2021, the patient experienced a neurological status deterioration: malignant sylvian infarction (edema and mass effect on early post-thrombectomy ct scan) associated with impaired alertness.) and a craniectomy was performed to treat the event.The patient experienced a life-threatening event.The patient was recovering from neurological status deterioration and was discharged to continuing care.No other information was provided.Update information: received additional information on 27-december-2021 stated that at the patient's 3-month follow-up, a blinded assessment of the mrs (modified rankin score) was performed by telephone on (b)(6) 2021.The current mrs is 3.Per physician¿s opinion, the subject trevo device performed as intended and there was no allegation against the subject trevo device.

Manufacturer Narrative

It was confirmed that the same reported event, product had already been entered and captured under (b)(4).Based on this update, this record ((b)(4)) along with associated children will be cancelled due this duplicate entry.Refer to (b)(4) for the continuation of the complaint process of the alleged issue associated with the subject complaint device.Therefore, this event does not meet the criteria of a complaint and will be canceled.B1 product problem: corrected: no adverse event.B2 outcomes attributed to ae : corrected : no outcomes attributed to ae.B5 executive summary: updated.H1 type of reportable event: corrected : no serious injury.Device code grid : corrected: no 'adverse event without identified device or use problem' f10 / h6 health effect - clinical code/ health effect - impact code: corrected to 'no health consequences or impact; and 'no clinical signs, symptoms or conditions'.

Event Description

It was reported that the patient with no specified medical history, had been received the experimental procedure (mechanical thrombectomy) on (b)(6) 2021 (randomization in experimental arm).On (b)(6) 2021, the patient experienced a neurological status deterioration: malignant sylvian infarction (edema and mass effect on early post-thrombectomy ct scan) associated with impaired alertness.) and a craniectomy was performed to treat the event.The patient experienced a life-threatening event.The patient was recovering from neurological status deterioration and was discharged to continuing care.No other information was provided.Update information: received additional information on 27-december-2021 stated that at the patient's 3-month follow-up, a blinded assessment of the mrs (modified rankin score) was performed by telephone on 21/10/2021.The current mrs is 3.Per physician¿s opinion, the subject trevo device performed as intended and there was no allegation against the subject trevo device.2nd update information: it was confirmed that the same reported event, product had already been entered and captured under pi# (b)(4).Based on this update, this record ((b)(4)) along with associated children will be cancelled due this duplicate entry.Refer to pi# (b)(4) for the continuation of the complaint process of the alleged issue associated with the subject complaint device.Therefore, this event does not meet the criteria of a complaint and will be canceled.

• Brand Name: TREVO XP PROVUE 3MM X 20MM
• 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: 12760288
• MDR Text Key: 280443114
• Report Number: 3012931345-2021-00182
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K133464
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 90183
• Device Lot Number: 40362971
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/03/2022
• 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: SOFIA 5 (MICROVENTION).; SOFIA 6 (MICROVENTION).
• Patient Outcome(s): Other; Life Threatening; Required Intervention; Hospitalization
• Patient Age: 51 YR
• Patient Sex: Male