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	Perforation of Vessels (2135); Cardiac Tamponade (2226); Vascular Dissection (3160)
Date of Event	04/12/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject device was returned for investigation and inspected.The reported failure of balloon rupture was confirmed.Balloon ruptures are 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 relationship between the balloon rupture and the patient's outcome could not be determined with the information available.This is a known inherent risk with the procedure and the use of the device.The associated patient risk for this failure mode is low and adequately captured in swmi's risk documentation.The root cause for the subsequent dissection, perforation, and tamponade could not be definitively determined based on the information available, and there was no malfunction reported for the second c2 ivl catheter used.The physician indicated that the lesion could not have been tackled without the use of ivl.The physician does not believe the ivl caused the perforation and attributes it to high pressure (non-shockwave) balloon dilation to crack residual calcium.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
A shockwave c2+ coronary intravascular lithotripsy (ivl) catheter was used to treat a highly calcified lesion in the left main coronary artery.A solarice balloon was used to predilate the vessel.The c2+ ivl catheter was then introduced, successfully delivering 10 pulses at 4 atm to the proximal lesion before the ivl balloon ruptured with no adverse effect to the patient.Another c2+ ivl catheter was used to treat the lesion, successfully delivering 120 pulses.It was noted that the patient experienced ischemia and nausea; therefore, ivl pulses were delivered at 3 pulses, then 5 pulses, then 7 pulses, and so on, rather than 10 pulses per sequence per the device ifu.A small dissection was observed at the bifurcation of the circumflex after ivl treatment.A vessel perforation occurred following the implantation of a drug-eluting stent (des) to treat the dissection.Two papyrus stents were implanted in the proximal and distal lesion; however, the leak remained, and the patient showed signs of cardiac tamponade which was successfully treated by thoracocentesis.A solarice balloon was then used to fully appose the papyrus stents, followed by an undersized ringer 4.0 mm balloon, showing a reduced leak.A third papyrus stent was delivered inside the des stent and to overlap the papyrus stent, successfully resolving the perforation.There were no additional patient sequelae reported and the patient outcome was successful following the 2 ½ hour procedure, the patient was transferred to the civu and discharged.The physician does not believe the ivl caused the perforation and attributes it to high pressure dilation to crack residual calcium.The physician believes the ivl likely caused the dissection but that it is not unexpected when the calified vessels are dilated.This report is for the first catheter used in the procedure (reference mdr 3015053858-2024-00045 for the second catheter).

• 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 95054
• MDR Report Key: 19294139
• Report Number: 3015053858-2024-00044
• Device Sequence Number: 8687558
• Product Code: QMG
• UDI-Device Identifier: 00195451000027
• UDI-Public: (01)00195451000027(17)251231(10)04C231207A
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/10/2024

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: 12/31/2025
• Device Model Number: C2PIVL3512
• Device Catalogue Number: C2PIVL3512
• Device Lot Number: 04C231207A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2024
• Initial Report FDA Received Date: 05/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/07/2023
• 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: PAPYRUS - STENT; RINGER - 4.0 MM BALLOON; SOLARICE - SEMI-COMPLIANT BALLOON
• Outcome Attributed to Adverse Event: Other
• Patient Age: 65 YR
• Patient Sex: Male