MAUDE Adverse Event Report: SHOCKWAVE MEDICAL, INC SHOCKWAVE L6 PERIPHERAL INTRAVASCULAR LITHOTRIPSY CATHETER

Model Number	L6IVL100030
Medical Device Problem Codes	Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	06/26/2023
Type of Reportable Event	Death
Additional Manufacturer Narrative
The devices referenced in this report were not returned to shockwave medical, inc.For investigation.Therefore, inspection of the device could not be performed.Based on the reported information, there was no ivl device malfunction.The physician believes that it was the steel core.018 wire that perforated the lv.The ivl device was used off label in an unapproved indication.Per the instructions for use (ifu), the device is only indicated for use in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries.A review of the lot history records (lhrs) and test documentation did not show any issues with the manufacturing of the devices.The devices passed all shockwave medical, inc.Criteria prior to being released for distribution.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.2nd device used during procedure: cp-11575.Lot number: a221214a.Expiration date: 12/31/2024.Manufacturing date: 12/14/2022.3rd device used during procedure: cp-11576.Lot number: a221214a.Expiration date: 12/31/2024.Manufacturing date: 12/14/2022.
Event or Problem Description
It was reported that a patient underwent a mitral valvuloplasty procedure to treat mitral stenosis using three shockwave l6 peripheral intravascular lithotripsy catheters.The procedure was performed off-label and the physician was aware of it.The ivls were introduced into the patient via transseptal puncture.During the procedure and after 60 pulses were delivered, the patient's blood pressure dropped.The physician immediately realized that the 0.018" steel core wire perforated the left ventricle (lv).The patient was transferred to the operating room (or) for open-heart surgery to fix the perforation and then moved to the intensive care unit (icu).While in the icu, the patient started to bleed again and then subsequently expired.All three ivl devices functioned as intended and no malfunction was reported.

• Brand Name: SHOCKWAVE L6 PERIPHERAL INTRAVASCULAR LITHOTRIPSY CATHETER
• Common Device Name: SHOCKWAVE L6 PERIPHERAL INTRAVASCULAR LITHOTRIPSY 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: 17290260
• Report Number: 3015053858-2023-00044
• Device Sequence Number: 5523538
• Product Code: PPN
• UDI-Device Identifier: 00195451000409
• UDI-Public: (01)00195451000409(17)241231(10)A221214A
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K221852
• 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): 06/26/2023

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: 12/31/2024
• Device Model Number: L6IVL100030
• Device Catalogue Number: L6IVL100030
• Device Lot Number: A221214A
• 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: 06/26/2023
• Initial Report FDA Received Date: 07/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 0.018" STEELE CORE WIRE - ABBOTT VASCULAR
• Outcome Attributed to Adverse Event: Death
• Patient Age: 76 YR
• Patient Sex: Female