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

Model Number	2.5 X 12MM
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Perforation (2001); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2023
Type of Reportable Event	Death
Event or Problem Description
It was reported that a patient with major cardiac decompensation underwent a percutaneous coronary intervention (pci) procedure using a shockwave c2 coronary intravascular lithotripsy (ivl).Access was obtained via the femoral artery with a 7f sheath.The ivl procedure was to treat a very calcified lesion located in the circumflex (cx) artery.The lesion was described as long, tortuous, diffused and extremely angulated/ tortuous.The physician first used a rotoblator to prepare the lesion for ivl treatment and then a subsequent stent implantation.After the ivl delivered 20 cycles of pulses, the balloon ruptured.Another ivl was successfully used to treat the circumflex (cx).The patient also has lesions in the bifurcation in the left main medina 1,1,1.Accordingly, the physician inflated the bifurcation using a 3.0mm balloon catheter but with undesired result.Due to the efficacity, the physician decided to inflate using a short non-compliant (nc) balloon outside of the cx in preparation for kissing-stent technique to reconstruct with bifurcation.The physician inflated the balloon to 10 atms and it perforated and massively ruptured the artery and resulted in patient's death.
Additional Manufacturer Narrative
The device referenced in this report has not yet been received at shockwave medical, inc.For investigation therefore, no investigation can be performed.A supplemental report will be submitted after the device is received and investigated.Based on the reported event, the perforation or rupture occurred when the physician inflated the non-compliant (nc) balloon to 10 atms to prepare the bifurcation for a kissing-stent technique.A review of the lot history record (lhr) and test documentation did not show any issues with the manufacturing of the device.The device 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.
Additional Manufacturer Narrative
The subject device referenced in this report was returned for investigation and inspected.All emitters showed signs of wear, indicating that they were fired as expected.Longitudinal rupture was noted over emitter #1.Signs of heat effects were noted on the edge of the rupture.No other damage was noted on the balloon surface.Delamination and scuff marks were noted on the catheter tip.No other damage was noted on the catheter tip.The reported right circumflex artery rupture occurred when the physician inflated the non-compliant (nc) balloon to 10 atms to prepare the bifurcation for a kissing-stent technique.The likely cause of the arterial rupture could not be determined.

• Brand Name: SHOCKWAVE IVL SYSTEM WITH THE SHOCKWAVE C2 CORONARY 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 ; 8777754846
• MDR Report Key: 18209469
• Report Number: 3015053858-2023-00069
• Device Sequence Number: 12598913
• Product Code: QMG
• UDI-Device Identifier: 00195451000089
• UDI-Public: (01)00195451000089(17)240930(10)A220919P
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P200039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/19/2025

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: 09/30/2024
• Device Model Number: 2.5 X 12MM
• Device Catalogue Number: C2IVL2512
• Device Lot Number: A220919P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2023
• Supplement Date Received by Manufacturer: 01/17/2024; 05/05/2025
• Initial Report FDA Received Date: 11/27/2023
• Supplement Report FDA Received Date: 01/22/2024; 05/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2022
• 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: 7F SHEATH - UNK MANUFACTURER; NON-COMPLIANT (NC) BALLOON; ROTOBLATOR ROTATIONAL ATHERECTOMY SYSTEM - BOSTON; SYNERGY¿ XD DRUG-ELUTING STENT
• Outcome Attributed to Adverse Event: Death
• Patient Age: 87 YR
• Patient Sex: Female