MAUDE Adverse Event Report: SHOCKWAVE MEDICAL, INC. SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER; INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER,

Model Number	C2IVL2512
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Cardiogenic Shock (2262)
Date of Event	05/16/2022
Type of Reportable Event	Death
Additional Manufacturer Narrative
The device referenced in this report was discarded by the user facility after the procedure therefore, a physical examination could not be performed.Based on the provided information, the patient coded and subsequently expired after a successful ivl procedure.The ivl device performed as intended; the cause for the cardiogenic shock experienced by the patient and subsequent death during the final stages of the intervention could not be conclusively determined with the information available.Shockwave medical 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
A shockwave c2 coronary intravascular lithotripsy (ivl) balloon was used in a patient who underwent a high-risk percutaneous coronary intervention (pci) to treat a highly calcified de novo lesion in the left anterior descending artery (lad).The ivl balloon successfully delivered 80 pulses.Post ivl, the target lesion was dilated with a non-compliant (nc) balloon to enlarge the opening and further expanded with a drug-eluting stent (des) using a kiss-pot (proximal optimization technique) across the ostial circumflex.The left main coronary artery (lmca) was also diseased and once stented with a medicated stent, visualization of the stents was seen to be widely open.At this time, the patient developed hypotension (bp dropped to 67/43 mmhg) and hearbeat rate of 48 and continued to decline.The patient's level of consciousness (loc) was impaired, and the oxygen level saturation (desats) was undetectable.The patient went into electromechanical dissociation (emd).The patient was given epinephrine boluses, cardiopulmonary resuscitation (cpr), cardioversion and intubation however, the patient coded and subsequently expired.

• Brand Name: SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER
• 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
• MDR Report Key: 14497899
• Report Number: 3015053858-2022-00030
• Device Sequence Number: 12062717
• Product Code: QMG
• UDI-Device Identifier: 00195451000089
• UDI-Public: 01001954510000891723103110
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P200039
• 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): 05/16/2022

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: 10/31/2023
• Device Model Number: C2IVL2512
• Device Catalogue Number: C2IVL2512
• Device Lot Number: A211012F
• 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: 05/16/2022
• Initial Report FDA Received Date: 05/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2021
• 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: BOLUS DOSES OF EPINEPHRINE; RESOLUTE DRUG-ELUTING STENT (DES) - MEDTRONIC
• Outcome Attributed to Adverse Event: Death
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White