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

Model Number	C2PIVL3512
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Atrial Fibrillation (1729); Cellulitis (1768); Myocardial Infarction (1969); Pericardial Effusion (3271); Thrombosis/Thrombus (4440); Heart Failure/Congestive Heart Failure (4446); Swelling/ Edema (4577)
Date of Event	05/13/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device referenced in this report was not returned to shockwave medical, inc.Therefore, a physical examination cannot be performed.The cause of the myocardial infarction and death could not be definitively determined based on the information available.Additionally, the clinical site determined that the pericardial effusion, thrombus, cellulitis, edema, encephalopathy, congestive heart failure, atrial fibrillation, were not related to ivl.There was no ivl malfunction reported.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
This event was reported to shockwave via the post market empower cad clinical study.A shockwave c2+ intravascular lithotripsy (ivl) catheter was used to treat a lesion in the coronary arteries.The ivl catheter successfully delivered 120 pulses.There was no report of an ivl device malfunction two days after the index procedure, the echocardiogram (echo) revealed minimal pericardial effusion around the right ventricle and thrombus.30 minutes after, the echo revealed no change.There was no intervention and dual antiplatelet therapy was given for six months for stents.The clinical site determined that there was no relationship between ivl and the pericardial effusion and thrombus.Two weeks after the index procedure, the patient got cellulitis with erythema and warmth with tenderness to bilateral lower extremities.Iv vancomycin was ordered which was then switched to ancef a month later.The clinical site determined that there was no relationship between ivl and cellulitis.Three weeks after the index procedure, the patient presented to the emergency room (er) with altered mental status.Magnetic resonance imaging (mri) was performed.There was no acute infarct but evidence of old left parietal lobe infarct and possible glioma due to a 2 cm well defined mass.The clinical site determined that there was no relationship between ivl and encephalopathy.A few weeks later, the patient presented to the er with significant lower extremity edema.The patient was then admitted, and the chest x-rays showed bilateral pleural effusions.The patient was put on supplemental o2 secondary to acute congestive heart failure (chf).Additionally, the patient had atrial fibrillation with a rapid ventricular rate.The patient had a history of paroxysmal atrial fibrillation (p-afib) with rapid ventricular response (rvr).Cardene iv gtt (intravenous glucose tolerance test) and metoprolol was given.The clinical site determined that there was no relationship between ivl and acute chf.On the same day, vascular was consulted for right great toe petechial discoloration.A lower extremity ultrasound demonstrated no evidence of deep vein thrombosis (dvt).It demonstrated bilateral severe stenosis and the occlusion of the left tibial posterior artery and right femoral and tibial arteries.The clinical site determined that there was no relationship between ivl and peripheral vascular disease.Two months after the index procedure, the patient presented with acute kidney injury and decompensated congestive heart failure.The patient was treated by medications and a bilevel positive airway pressure (bipap).The clinical site determined that there was no relationship between ivl and the acute kidney injury and decompensated congestive heart failure.A few days later, the patient was discharged to hospice care and passed away.This event was sent to the clinical events committee (cec) for adjudication of the myocardial infarction.Cec has determined that myocardial infarction is possible to the study device and definite to the procedure.The committee indicated that the possible relationship to the device is because film was reviewed, and the troponin levels were greater than 70 x uln.

• 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: 20025877
• Report Number: 3015053858-2024-00094
• Device Sequence Number: 7336060
• Product Code: QMG
• UDI-Device Identifier: 00195451000027
• UDI-Public: (01)00195451000027(17)251231(10)02A231218A
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 08/20/2024

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: 12/31/2025
• Device Model Number: C2PIVL3512
• Device Catalogue Number: C2PIVL3512
• Device Lot Number: 02A231218A
• 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: 07/22/2024
• Initial Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/18/2023
• 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: SYNERGY XD DRUG ELUTING STENT - BOSTON SCIENTIFIC; SYNERGY XD DRUG ELUTING STENT - BOSTON SCIENTIFIC
• Outcome Attributed to Adverse Event: Hospitalization; Death
• Patient Age: 80 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White