MAUDE Adverse Event Report: SHOCKWAVE MEDICAL, INC. SHOCKWAVE M5+ PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER

Model Number	M5PIVL7060
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Low Blood Pressure/ Hypotension (1914)
Date of Event	08/20/2024
Type of Reportable Event	Death
Additional Manufacturer Narrative
The device referenced in this report was not returned to shockwave medical, inc.Therefore, a physical examination cannot be performed.Based on the reported information, there was difficulty advancing or removing the valve, and the 18f sheath became stuck in the artery which may have contributed to the drop in blood pressure and subsequent bleeding and death; however, this could not be definitively determined based on the information available.There was no ivl malfunction reported for the m5+ ivl catheter, and the l6 ivl catheter was not used in the patient.Shockwave medical has controls in place to ensure devices are built to approved procedures and meet lot release acceptance criteria prior to being distributed.A review of the manufacturing and test documentation for subject lot does not reveal any issues with the manufacturing of the device.The device passed all of shockwave medical, inc.Acceptance criteria prior to shipping.
Event or Problem Description
A shockwave m5+ peripheral intravascular lithotripsy (ivl) catheter was used to treat a lesion in the iliac arteries prior to placing a 26 aortic valve.The physician chose the m5+ 7.0 mm ivl catheter based on disease process, vessel size, and diameter needed to advance the aortic valve.The length of the common iliac and external iliac arteries were treated with all 300 pulses of the ivl device.The physician advanced the 16f dilator without resistance, but met resistance when attempting to advance the 18f delivery sheath.The physician asked for an l6 8.0 mm ivl catheter; however, while the l6 device was being opened and prepped, the physician made a second attempt to cross the lesion with the 18f sheath, and the sheath advanced.At that point, the physician made the decision not to treat the vessel any further and to proceed with the insertion and placement of the valve.As the physician was advancing the valve through the sheath, the valve got stuck near the area of stenosis within the sheath.There was difficulty advancing or removing the valve as the sheath had expanded and became stuck in the artery.The physician attempted to remove the sheath, and the patient experienced a drastic drop in blood pressure.An aortic balloon was eventually placed to control suspected bleeding.Vascular surgery was called, and the sheath was removed, with what appeared to be intimal tissue on the sheath.The patient coded and cardiopulmonary resuscitation (cpr) was initiated.The vascular surgeon placed covered stents throughout the common and external iliac arteries, but they were unable to control the patient's bleeding.Compressions and defibrillation continued for over two hours.An impella was eventually placed, and a lucas mechanical compression device was utilized to remove the patient from the lab and transfer him to the intensive care unit (icu).The plan was to discontinue compressions, with the understanding that the patient would expire.The patient expired the same day as the procedure.

• Brand Name: SHOCKWAVE M5+ PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER
• Common Device Name: SHOCKWAVE M5+ PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER
• Manufacturer (Section D): SHOCKWAVE MEDICAL, INC.; 5403 betsy ross drive; santa clara CA 95054
• Manufacturer (Section G): SHOCKWAVE MEDICAL, INC.; 5403 betsy ross drive; santa clara CA 95054
• Manufacturer Contact: alexis weil ; 5403 betsy ross drive; santa clara, CA 95054
• MDR Report Key: 20242046
• Report Number: 3015053858-2024-00105
• Device Sequence Number: 8516894
• Product Code: PPN
• UDI-Device Identifier: 00195451000270
• UDI-Public: (01)00195451000270(17)251130(10)82298781
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K203365
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/17/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2025
• Device Model Number: M5PIVL7060
• Device Catalogue Number: M5PIVL7060
• Device Lot Number: 82298781
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2024
• Initial Report FDA Received Date: 09/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/24/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 16F DILATOR - UNKNOWN MANUFACTURER; 18F DELIVERY SHEATH - UNKNOWN MANUFACTURER; 26 AORTIC VALVE - UNKNOWN MANUFACTURER; AORTIC BALLOON - UNKNOWN MANUFACTURER; COVERED STENT - UNKNOWN MANUFACTURER; IMPELLA - ABIOMED; LUCAS MECHANICAL COMPRESSION DEVICE
• Outcome Attributed to Adverse Event: Other; Death
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Race: White