MAUDE Adverse Event Report: SHOCKWAVE MEDICAL, INC. SHOCKWAVE L6 PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) SYSTEM; INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER

Model Number	L6IVL100030
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hematoma (1884); Retroperitoneal Hemorrhage (4483)
Date of Event	05/15/2023
Type of Reportable Event	Death
Event or Problem Description
It was reported that a patient underwent a procedure where two shockwave l6 peripheral intravascular lithotripsy (ivl) catheters were used as part of an overall endovascular treatment plan.The catheters were used during the case to treat severely calcified lesions in the right and left common iliac arteries.The ivl balloons functioned properly during the case, delivering 60 pulses each at approximately 4 atmospheres.The balloons were used to pre-treat each artery before deploying stent graft in each artery.Reportedly, post procedure, the patient experienced retroperitoneal bleed.The patient was brought back in the cath lab however, the patient expired.
Additional Manufacturer Narrative
The devices referenced in this report were not returned to shockwave medical, inc.For investigation therefore, a physical examination could not be performed.The cause of the reported retroperitoneal bleed that the patient experienced could not be definitively determined.Based on the reported event, both l6 ivl devices successfully delivered pulses and functioned as intended.A review of the lot history records (lhrs) and test documentations did not show any issues with the manufacturing of the devices.The devices 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.2nd shockwave l6 peripheral lithotripsy (ivl) catheter model/catalog; number: l6ivl120030, lot number: a230201a, expiration date: 02/28/2025, mfg date: 02/01/2023, udi #: (b)(4).

• Brand Name: SHOCKWAVE L6 PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) SYSTEM
• Common Device Name: INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER
• 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: 17074891
• Report Number: 3015053858-2023-00033
• Device Sequence Number: 17674719
• Product Code: PPN
• UDI-Device Identifier: 00195451000409
• UDI-Public: (01)00195451000409(17)241231(10)A221219M
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K221852
• 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): 05/23/2023

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: 12/31/2024
• Device Model Number: L6IVL100030
• Device Catalogue Number: L6IVL100030
• Device Lot Number: A221219M
• 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: 05/23/2023
• Initial Report FDA Received Date: 06/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/19/2022
• 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: BARD ANGIOPLASTY BALLOONS - BARD MEDICAL; GORE® VBX STENT GRAFT - GORE MEDICAL
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown