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

Model Number UNKNOWN

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

Patient Problems Thrombosis/Thrombus (4440); Insufficient Information (4580)

Event Type  Death  

Manufacturer Narrative

The device referenced in this publication was not returned therefore, a physical examination could not be performed.Based on the provided information, the patient expired due to fatal in-stent thrombosis that occurred during the in-hospital period (five days after a pci).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 Description

Publication: 2022 rola intravascular lithotripsy as a novel treatment method for calcified unprotected left main diseases-comparison to rotational atherectomy-short-term outcomes.A retrospective analysis of a dataset from a registry conducted in two cooperative, high-volume pci cardiac centers.The 15 subjects in this study were carefully selected from all consecutive patients with calcified lesions who had undergone pci, and who required additional lesion preparation with either rotational atherectomy or shock wave intravascular lithotripsy for lm diseases (main inclusion criteria to study).Procedural outcomes (reference table 3 of the publication): within the publication, it was noted that the patient expired due to fatal in-stent thrombosis that occurred during the in-hospital period (five days after a pci).

• Brand Name: SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER
• Type of Device: 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
• MDR Report Key: 15221994
• MDR Text Key: 297853748
• Report Number: 3015053858-2022-00049
• Device Sequence Number: 1
• Product Code: QMG
• 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: Foreign,Study,Literature,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/02/2022

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 Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/02/2022
• Initial Date FDA Received: 08/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Death