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

Model Number C2IVL3512

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Arrest (1762); Thrombosis/Thrombus (4440)

Event Date 01/12/2022

Event Type  Death  

Event Description

A shockwave coronary c2 intravascular lithotripsy (ivl) catheter was used to treat the right coronary artery (rca) of a de novo lesion with concentric calcium.Ivus was used but could not pass.Ivus was then followed by a 2.5mm non-compliant (nc) balloon, which successfully crossed, and ivus was then successfully used.The shockwave ivl catheter was advanced but did not cross the lesion.A 2.5 nc balloon was then used with a guideliner inside a guide for additional guide support.The ivl catheter was then able to be delivered to the tightest part of the lesion; however, could not reach the most distal section.Following ivl treatment, the vessel was patent with no evidence of dissections or perforations.It was noted that the shockwave device was the last device in the patient.It was reported that the patient went into cardiac arrest necessitating resuscitation twice during the procedure, and the patient subsequently expired.The physician does not believe the shockwave ivl was the cause of the patient's passing but thought it was possible there was a thrombus caused by other non-shockwave gear, and a possible heparin issue.The event is likely related to the procedure, but not the device.

Manufacturer Narrative

The complaint device was returned by the reporting party.Device was received in 2 pieces.Break in the shaft was located 4 cm away from the distal end of the strain relief.The break in the shaft and kinks are attributed to handling after the procedure, as the reporting party confirmed there was no damage noted during the procedure.The root cause for the reported failure of having difficulty crossing the lesion could not be confirmed, however, it was noted that the catheter was able to advance to the tightest part of the lesion but not the most distal.The cause for the catheter not being able to fully cross during the procedure is likely due to the tight lesion in the vessel.The physician does not believe the shockwave ivl was the cause of the patient's passing but thought it was possible there was a thrombus caused by other non-shockwave gear, and a possible heparin issue.The event is likely related to the procedure, but not the device.A review of the manufacturing and test documentation did not reveal any issues with the manufacturing of the device.The device passed all of swmi's acceptance criteria prior to shipping.

Manufacturer Narrative

The complaint device was returned by the reporting party.Device was received in 2 pieces.Break in the shaft was located 4 cm away from the distal end of the strain relief.The break in the shaft and kinks are attributed to handling after the procedure, as the reporting party confirmed there was no damage noted during the procedure.The root cause for the reported failure of having difficulty crossing the lesion could not be confirmed, however, it was noted that the catheter was able to advance to the tightest part of the lesion but not the most distal.The cause for the catheter not being able to fully cross during the procedure is likely due to the tight lesion in the vessel.The physician does not believe the shockwave ivl was the cause of the patient's passing but thought it was possible there was a thrombus caused by other non-shockwave gear, and a possible heparin issue.The event is likely related to the procedure, but not the device.A review of the manufacturing and test documentation did not reveal any issues with the manufacturing of the device.The device passed all of swmi's acceptance criteria prior to shipping.

Event Description

A shockwave coronary c2 intravascular lithotripsy (ivl) catheter was used to treat the right coronary artery (rca) of a de novo lesion with concentric calcium.Ivus was used but could not pass.Ivus was then followed by a 2.5mm non-compliant (nc) balloon, which successfully crossed, and ivus was then successfully used.The shockwave ivl catheter was advanced but did not cross the lesion.A 2.5 nc balloon was then used with a guideliner inside a guide for additional guide support.The ivl catheter was then able to be delivered to the tightest part of the lesion; however, could not reach the most distal section.Following ivl treatment, the vessel was patent with no evidence of dissections or perforations.It was noted that the shockwave device was the last device in the patient.It was reported that the patient went into cardiac arrest necessitating resuscitation twice during the procedure, and the patient subsequently expired.The physician does not believe the shockwave ivl was the cause of the patient's passing but thought it was possible there was a thrombus caused by other non-shockwave gear, and a possible heparin issue.The event is likely related to the procedure, but not the device.

• Brand Name: SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER
• Type of Device: 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: 13502077
• MDR Text Key: 285385079
• Report Number: 3015053858-2022-00007
• Device Sequence Number: 1
• Product Code: QMG
• UDI-Device Identifier: 00195451000102
• UDI-Public: (01)00195451000102(17)231031(10)A211005F
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P200039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/12/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: C2IVL3512
• Device Catalogue Number: C2IVL3512
• Device Lot Number: A211005F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/12/2022
• Initial Date FDA Received: 02/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/05/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 2.5 NC BALLOON - UNKNOWN MFGR.; 6F GUIDE - UNKNOWN MFGR.; GODZILLA GUIDELINER - MFG: BOSON SCIENTIFIC; IVUS - UNKNOWN MFGR
• Patient Outcome(s): Death
• Patient Sex: Male