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

Model Number	C2IVL3012
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Hemorrhage/Blood Loss/Bleeding (1888); Perforation (2001)
Date of Event	09/29/2022
Type of Reportable Event	Death
Additional Manufacturer Narrative
The device referenced in this report was not returned to shockwave medical, inc.Therefore, a physical examination could not be performed.There was no ivl device malfunction reported.Based on the provided information, the patient experienced left circumflex (lcx) and left main (lm) artery perforations.Covered stents were immediately deployed however, under imaging, there was still presence of bleeding.The patient was emergently transferred to the operating room for surgery to stop the bleeding.However, the patient coded and subsequently expired.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.
Event or Problem Description
It was reported that after a patient had a ventricular heart pump procedure due to coronary artery disease (cad), the patient underwent a percutaneous coronary intervention (pci) using the shockwave c2 coronary intravascular lithotripsy (ivl) catheter to treat a concentric de novo lesion located in the proximal left anterior coronary (lad) and circumflex (cx) arteries.The balloon successfully delivered 40 pulses in each vessel.Post ivl procedure, a drug-eluting stents (des) were deployed in the left circumflex and proximal lad.The lad and the cx were post-dilated with non-compliant (nc) balloons.Following post-dilatation and contrast injection, the patient's blood pressure was observed to be dropping.After further imaging, it was discovered that the left cx and the left main (lm) were perforated.Covered stents were immediately deployed to treatment the perforations.Angiography showed the bleeding had subsided however, due to the stability of the patient, and the echogram still showing bleeding, the patient was emergently transported to the operating room (or) for surgery to stop the bleeding.After the surgery, the patient was transferred back to the icu on impella support and was returned to surgery the following morning in an attempt to find and stop the bleeding, which was unsuccessful, and the patient coded and subsequently expired.

• Brand Name: SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IV) CATHETER
• Common Device Name: INTRAVASCULAR LITHOTRIPSY (IV) 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
• MDR Report Key: 15632396
• Report Number: 3015053858-2022-00062
• Device Sequence Number: 17620138
• Product Code: QMG
• UDI-Device Identifier: 00195451000096
• UDI-Public: (01)00195451000096(17)240331(10)A220324B
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 09/29/2022

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: 03/31/2024
• Device Model Number: C2IVL3012
• Device Catalogue Number: C2IVL3012
• Device Lot Number: A220324B
• 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: 09/29/2022
• Initial Report FDA Received Date: 10/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2022
• 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: IMPELLA VENTRICULAR SUPPORT SYSTEM - ABIOMED.; NON-COMPLIANT BALLOON CATHETERS - UNK MANUFACTURER.; PK PAPYRUS CONVERED STENTS - BIOTRONIK.; RESOLUTE ONYX DRUG-ELUTING STENT (DES) - MEDTRONIC.
• Outcome Attributed to Adverse Event: Death
• Patient Age: 86 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White