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

Model Number	C2IVL3512
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	11/03/2021
Type of Reportable Event	Death
Event or Problem Description
A shockwave c2 intravascular lithotripsy (ivl) device was used to treat a heavily calcified de novo lesion at the left anterior descending (lad) artery.The physician pre-dilated the lesion with two different sized balloons and then activated the ivl balloon catheter.It successfully delivered 40 pulses at 4 atmospheres followed by a successful promus drug-eluting stent (des) placement.After post dilatation of the stent using a 3.5 mm non-compliant (nc) balloon, the physician realized there was an arterial perforation.It was reported that the patient refused to undergo a coronary artery bypass graft (cabg).The patient opted for an endovascular approach.The physician inserted a balloon catheter to tamponade the bleeding followed by a covered stent placement.At this time, cardiopulmonary resuscitation (cpr) began, but the patient did not make it and expired on the table.The physician believes that the ivl balloon catheter performed well, and it did not contribute to the adverse event.
Additional Manufacturer Narrative
The device referenced in this report was returned to shockwave medical, inc.For investigation.Visual inspection did not show any tears or pinholes on the balloon.The emitters showed signs of wear, an indication that they have been fired.The operating physician indicated that the ivl therapy performed as intended and was not at fault.The perforation occurred during post dilation of the stent (non-shockwave product) using a non-compliant (nc) balloon (non-shockwave product).Based on this information, shockwave medical is of the opinion that the adverse event is not related to the ivl system.Based on the investigation of the device, the reported event of device malfunction could not be confirmed.Shockwave medical, inc.Has controls in place to ensure devices are built to approved procedures and met lot release acceptance criteria prior to being distributed.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.

• Brand Name: SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER
• Common Device Name: NTRAVASCULAR 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
• MDR Report Key: 12913137
• Report Number: 3015053858-2021-00025
• Device Sequence Number: 4946264
• Product Code: QMG
• UDI-Device Identifier: 00195451000102
• UDI-Public: (01)00195451000102(17)230331
• 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): 11/04/2021

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: 03/31/2023
• Device Model Number: C2IVL3512
• Device Catalogue Number: C2IVL3512
• Device Lot Number: A210318K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2021
• Initial Report FDA Received Date: 12/01/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/18/2021
• 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: NON-COMPLIANT (NC) BALLOON - UNKNOWN MANUFACTURER; SYNERGY STENT - BOSTON SCIENTIFIC
• Outcome Attributed to Adverse Event: Death
• Patient Age: 70 YR
• Patient Sex: Male