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

Model Number	C2PIVL2512
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Chest Pain (1776); Vascular Dissection (3160)
Date of Event	07/10/2024
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 chest pain and dissection could not be definitively determined based on the information available.There was no ivl malfunction reported.The physician attributed the complication to a dissection in the lm.The dissection was treated with a balloon and stent.Notably, the lesion treated initially with shockwave therapy was approximately 40-50mm away from the dissection site.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 coronary c2+ intravascular lithotripsy (ivl) catheter was used to treat a lesion in the mid proximal left anterior descending artery (lad).90 pulses were delivered at pressures of 4 to 6 atm.A 2.5x48mm synergy stent was placed and post-dilated with a 3.0 non-compliant (nc) balloon.The final imaging showed successful results.There was no reported ivl malfunction.30 minutes post procedure, the patient was complaining of severe chest pain.Meds were given to help with the pain and vitals appeared good, but the pain increased to 10/10.The physician chose to proceed with right groin access to perform another angiogram.Lucency was observed in distal left main (lm) at the lad/circumflex (cx)bifurcation and a re-intervention was initiated.Both cx and lad were wired using a 3.0x15mm balloon to pre-dilate the lesion on the lad wire at distal lm and then the balloon was returned to pre-dilate lm-proximal cx.A 3.0x20mm synergy stent was placed in the proximal cx and post dilated with a 3.0x20 nc balloon.A 3.5x20mm synergy stent was then placed from lm to proximal lad and post dilated lm with a 4.5x15 nc balloon.The patient's blood pressure dropped necessitating the use of impella support.Once on impella support, 3.0x15 balloons were placed over each wire to do a "kissing" technique at bifurcation.An intravascular ultrasound (ivus) was then utilized to check stent apposition and confirmed all stents were well apposed and expanded.Final imaging showed good results.The physician attributed the complication to a dissection in the lm.The dissection was treated with a balloon and stent.Notably, the lesion treated initially with shockwave therapy was approximately 40-50mm away from the dissection site.The patient was subsequently transferred to the icu on impella support.The patient is currently doing well.

• 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: 19933885
• Report Number: 3015053858-2024-00091
• Device Sequence Number: 2760283
• Product Code: QMG
• UDI-Device Identifier: 00195451000003
• UDI-Public: (01)00195451000003(17)250731(10)11A230713A
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 08/07/2024

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: 07/31/2025
• Device Model Number: C2PIVL2512
• Device Catalogue Number: C2PIVL2512
• Device Lot Number: 11A230713A
• 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: 07/10/2024
• Initial Report FDA Received Date: 08/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/13/2023
• 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: 2.5X48MM SYNERGY STENT - UNKNOWN MANUFACTURER; 3.0MM NC BALLOON - UNKNOWN MANUFACTURER; 3.0X15MM NC BALLOON - UNKNOWN MANUFACTURER; 3.0X20MM NC BALLOON - UNKNOWN MANUFACTURER; 3.0X20MM SYNERGY STENT - UNKNOWN MANUFACTURER; 3.5X20MM SYNERGY STENT - UNKNOWN MANUFACTURER; 4.5X15MM NC BALLOON - UNKNOWN MANUFACTURER; IMPELLA HEART PUMP - ABIOMED
• Outcome Attributed to Adverse Event: Other
• Patient Age: 86 YR
• Patient Sex: Female