MAUDE Adverse Event Report: SHOCKWAVE MEDICAL, INC. SHOCKWAVE M5 PLUS PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) SYSTEM; INTRAVASCULAR LITHOTRIPSY (IVL) BALLOON

Model Number	M5PIVL8060
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Perforation (2001); Retroperitoneal Hemorrhage (4483)
Date of Event	06/22/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device referenced in this report was not returned to shockwave medical, inc.After the procedure therefore, a physical examination could not be performed.Based on the provided information, the patient experienced artery dissection which was treated with a covered stent to control the bleeding.However, a retroperitoneal bled also occurred and the vascular surgeon performed a cutdown and inserted a drainage to remove fluid from the pericardial sac.A review of the lot history record (lhr) and test documentation did not show any issues with the manufacturing of the device.The device passed all shockwave medical, inc.Criteria prior to being released for distribution.Shockwave medical, inc.Has controls in place to ensure devices are built to approved procedures and meet lot release acceptance criteria prior to being distributed.
Event or Problem Description
It was reported that a patient underwent an endovascular aneurysm repair (evar) procedure to treat the left external iliac with a shockwave m5+ peripheral lithotripsy (ivl) catheter.After the ivl successfully delivered 210 pulses, it was removed from the patient's anatomy.The ivl balloon was re-prepped and while flushing the guidewire port, the balloon inflated causing a connection between the balloon and guidewire ports.Another ivl was prepared and used, and it successfully delivered an additional 100 pulses.After the ivl procedure, the physician used an 8.0mm angioplasty balloon which was pressurized to 12 atmospheres to post dilate the iliac artery.On first inflation, the balloon ruptured causing a perforation.The physician immediately used a covered stent to control the bleeding.However, the patient experienced retroperitoneal bleed and the vascular surgeon had to perform a peri-procedure cutdown to insert a drainage.The patient is reported to be stable and is doing well.The physician and the vascular surgeon stated that the use of the angioplasty balloon was causal to the iliac artery perforation and not the ivl.The comment made by the physician was that without the shockwave m5+ peripheral lithotripsy (ivl) catheter, they would not have been able to deliver anything through the artery.

• Brand Name: SHOCKWAVE M5 PLUS PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) SYSTEM
• Common Device Name: INTRAVASCULAR LITHOTRIPSY (IVL) BALLOON
• Manufacturer (Section D): SHOCKWAVE MEDICAL, INC.; 5403 betsy ross drive; santa clara CA 95054
• Manufacturer Contact: alexis weil ; 5403 betsy ross drive; santa clara, CA 95054 ; 8777754846
• MDR Report Key: 17239840
• Report Number: 3015053858-2023-00042
• Device Sequence Number: 14767524
• Product Code: PPN
• UDI-Device Identifier: 00195451000287
• UDI-Public: (01)00195451000287(17)250228(10)82277329
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/26/2023

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: 02/28/2025
• Device Model Number: M5PIVL8060
• Device Catalogue Number: M5PIVL8060
• Device Lot Number: 82277329
• 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: 06/26/2023
• Initial Report FDA Received Date: 06/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2023
• 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: COVERED STENT - UNKNOWN BRAND /MAUFACTURER
• Outcome Attributed to Adverse Event: Other; Hospitalization; Required Intervention
• Patient Sex: Male