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

Model Number	C2PIVL3512
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Codes	Myocardial Infarction (1969); Perforation (2001); Ventricular Fibrillation (2130); Hemodynamic instability (4868)
Date of Event	01/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A shockwave c2+ coronary intravascular lithotripsy catheter was used to treat a lesion in the mid left anterior descending arteries.The patient had a target lesion stenosis of 90% with a severe degree of calcification.The vessel was pre-dilated using a semi-compliant balloon.During ivl treatment, 60 pulses were delivered at 6atm prior to a balloon loss of pressure which is off label per instructions for use.It was reported that the target vessel perforation was observed via angiography which led to compromised coronary flow, hemodynamic instability, and periprocedural myocardial infarction.There was no pericardial effusion observed via echocardiography and a balloon tamponade was performed.The patient also experienced two episodes of ventricular fibrillation in which the patient was provided defibrillation.An impella cardiac power device was inserted to improve the patient's blood flow and two drug eluding stents (des) were placed into the vessel.Intravascular ultrasound (ivus) showed under expansion of the stent which was dilated with a non-compliant balloon.Repeat ivus then showed the stent well expanded with no dissection, perforation, or thrombus.The impella was weaned and the patient was transferred to the icu.The clinical site has determined that the myocardial infarction was definitely related to the device and procedure.
Additional Manufacturer Narrative
The device referenced in this report was not returned to shockwave medical, inc.Therefore, a physical examination cannot be performed.It was noted that ivl treatment was performed at 6atm which is off-label per instructions for use and may have contributed to the balloon loss of pressure and subsequent perforation, myocardial infarction, and ventricular fibrillation.However, this could not be definitively confirmed based on the information available.Balloon loss of pressure (rupture, pinhole) is a known failure mode with a low probability of occurrence.Contributing factors include patient calcium, damage caused when the balloon wall comes into close contact with the device emitters, likely causes include (a) an irregular calcium lesion capable of compressing the balloon wall into close proximity with the emitter(s) and/or (b) an incompletely inflated balloon.The associated patient risk for this failure mode is low and adequately captured in swmi's risk documentation.The shockwave intravascular lithotripsy (ivl) system with the shockwave c2+ coronary ivl catheter generates acoustic pressure pulses within the target treatment site, disrupting calcium within the lesion allowing subsequent dilatation of a coronary artery stenosis using low balloon pressure not to exceed 4 atm during ivl treatment, and 6 atm for post dilatation.The pressure used for the ivl balloon catheter is much lower than other balloon catheters used in percutaneous coronary intervention (pci), thus the risk associated with loss of balloon pressure during ivl catheter use is negligible.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.

• Brand Name: SHOCKWAVE C2+ CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER
• Common Device Name: SHOCKWAVE C2+ CORONARY 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: 19271677
• Report Number: 3015053858-2024-00039
• Device Sequence Number: 17891736
• Product Code: QMG
• UDI-Device Identifier: 00195451000027
• UDI-Public: (01)00195451000027(17)250630(10)02A230616A
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P200039/S008
• 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): 05/08/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2025
• Device Model Number: C2PIVL3512
• Device Catalogue Number: C2PIVL3512
• Device Lot Number: 02A230616A
• 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: 04/09/2024
• Initial Report FDA Received Date: 05/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/16/2023
• 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: IMPELLA CARDIAC POWER - ABIOMED.; RESOLUT ONYX DRUG ELUDING STENT - MEDTRONIC.; SEMICOMPLIANT BALLOON DILATATION CATHETER-SPRINTER.
• Outcome Attributed to Adverse Event: Life Threatening; Hospitalization; Required Intervention
• Patient Age: 80 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White