MAUDE Adverse Event Report: RAPID MEDICAL LTD. TIGERTRIEVER REVASCULARIZATION DEVICE; TIGERTRIEVER XL

Model Number TRPP3133

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

Patient Problems Stenosis (2263); Foreign Body In Patient (2687)

Event Date 05/21/2021

Event Type  Death  

Manufacturer Narrative

According to the report received by the company, the patient arrived to the hospital in severe condition (multiple occlusions were observed in a number of territories).The ica occlusion was treated with the subject device, however, stenosis was observed throughout the ica that may have been a contributing factor.There is no indication that the device, labeling or packaging failed to meet its specifications when deployed.It could not be conclusively determined if the device failed to meet specifications because the product was not returned.Because the review and analysis of all available information failed to identify a specific cause and the device was not returned, an assignable cause of undeterminable' will be assigned to this complaint.

Event Description

Adverse event description: rapid medical received a report of an adverse event concerning a tigertriever xl stentriever device, during a procedure in a hospital outside the united states.Although tigertriever xl is not cleared in the us, the event is being reported by the company because the tigertriever xl is in the product family that includes other tigertriever models that are cleared in the us.A (b)(6) year-old female patient presented to the hospital with a left internal carotid artery (ica) occlusion.Several aspiration attempts were made with sophia 6fr aspiration device.Additionally, a trevo stentriever was used prior to use of tigertriever xl.It was reported that reperfusion was achieved in the m1 segment, and partial reperfusion was achieved in the ica segment.Following, the physician attempted a pass with the tigertriever xl.During the first pass attempt, the device became immobilized, and the physician was unable to retrieve it.The physician attempted to advance the microcatheter toward the clot without success.It was reported that the lesion territory may have included stenosis and/or a large segment of atherosclerotic plaque.It was reported that the physician pulled on the device with significant force, causing the wire to fracture and leaving part of the tigertriever xl in the patient's ica.During the procedure, additional strokes were observed in the right cerebrovascular territory.The patient expired three days after the intervention.

• Brand Name: TIGERTRIEVER REVASCULARIZATION DEVICE
• Type of Device: TIGERTRIEVER XL
• Manufacturer (Section D): RAPID MEDICAL LTD.; carmel building po box 337; yokneam, israel 20692 05; IS 2069205
• MDR Report Key: 12180279
• MDR Text Key: 261909368
• Report Number: 3015531723-2021-00004
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 07290015107198
• UDI-Public: (01)07290015107198(17)230228(10)201001TX01
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/04/2021,06/17/2021

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 Expiration Date: 02/28/2023
• Device Model Number: TRPP3133
• Device Catalogue Number: TRPP3133
• Device Lot Number: 201001TX01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/15/2021
• Device Age: 9 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/04/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 65 YR