FDA Adverse Event Injury Summary report: N

TIGERTRIEVER REVASCULARIZATION DEVICE

MDR report key: 20877716 · Received December 9, 2024

Report

Report Number: 3015531723-2024-00004
Event Type: Injury
Date Received: December 9, 2024
Date of Event: November 16, 2025
Report Date: December 9, 2024
Manufacturer: RAPID MEDICAL INC
Product Code: NRY
UDI-DI: 1290015107270
Adverse Event: Yes
Report Source: Distributor report
Reporter Location: NY, US
Reporter Occupation: PHYSICIAN
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

BASED ON THE PROCEDURAL INFORMATION PROVIDED, THE RUPTURE OF A SMALL LEFT M2 VESSEL, LOCATED MEDIAL TO THE OCCLUDED VESSEL, OCCURRED IN AN AREA WHERE THE DEVICE WAS NOT PRESENT OR IN CONTACT WITH THE VESSEL WALL. A THOROUGH REVIEW OF THE AVAILABLE DATA, INCLUDING PROCEDURAL DETAILS, DID NOT IDENTIFY ANY INDICATION OF DEVICE MALFUNCTION. FURTHERMORE, THERE IS NO CONCLUSIVE EVIDENCE TO SUGGEST THAT THE TIGERTRIEVER 17 CONTRIBUTED TO THE VESSEL RUPTURE. THE EVENT APPEARS TO BE UNRELATED TO THE FUNCTION OR USE OF THE DEVICE, AND OTHER PROCEDURAL OR ANATOMICAL FACTORS MAY HAVE BEEN INVOLVED.

Description of Event or Problem · 0

A 63-YEAR-OLD MALE WITH A PAST MEDICAL HISTORY INCLUDING HYPERTENSION, AND ATRIAL FIBRILLATION, WAS COMMERCIALLY TREATED WITH THE TIGERTRIEVER 17 DEVICE ON (B)6)2024. THE PATIENT WAS PRESENTED TO THE HOSPITAL DUE TO A STROKE DEMONSTRATED ON BRAIN CT THAT REVEALED LEFT CO-DOMINANT MCA - M2 OCCLUSION. DURING THE PROCEDURE WITH TIGERTIREVER-17, A RUPTURE OF A SMALL LEFT M2 VESSEL MEDIAL TO THE OCCLUDED VESSEL OCCURRED AND THE PROCEDURE WAS ABORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
337529	TIGERTRIEVER REVASCULARIZATION DEVICE	TIGERTRIEVER 17,	NRY	RAPID MEDICAL INC	TRPP7166	240512TS01	1290015107270

Patients

Seq	Age	Sex	Outcome	Treatment
1	63 YR	Male	Required Intervention\| H