MAUDE Adverse Event Report: SHOCKWAVE MEDICAL, INC S4 IVL PERIPHERAL CATHETER; BALLOON CATHETER

Model Number	FG63091-2540
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Death (1802)
Date of Event	03/04/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
The complaint device was not returned by the reporting party as it was discarded by the physician.Therefore, inspection of the device could not be performed.There was no device malfunction noted during the procedure, and the review of the manufacturing and test documentation records do not suggest any issues with the device.The device passed all acceptance criteria prior to shipping.The shockwave s4 ivl catheter is indicated as follows: the shockwave medical ivl system is intended for lithotripsy-enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries.Not for use in the coronary or cerebral vasculature.Per available complaint information, the shockwave peripheral ivl device was operated in a coronary setting in an off label manner.The patients pre-existing condition is likely a contributory factor for the adverse event.
Event or Problem Description
The physician wanted to use shockwave off label as he felt it was the best option.He was going to be treating a heavily calcified left anterior descending artery (lad) that had disease from mid to distal lad.The circumflex artery was bypassed due to disease and a narrow left main.The doctor first stented the left main artery (lm) to allow his guide to engage better but also to allow him to use a guideliner.Following that he pre-dilated with a 2.5x30 balloon.The calcification was 30-40mm in length.Following that a 2.5x40 ivl catheter was inserted but due to the disease the catheter was only able to pass about a quarter of the way down.The doctor decided to inflate, at 2atm and 5 pulses were delivered, subsequently the patient started to brady down (heart beat dropping).Ivl device was removed, angiogram was performed with contrast, and no perforation noted.The physician decided he would abort ivl and go with standard balloon/stent approach to fix the lad.The physician decided to treat further with balloons (standard & nc).The physician tried to use a guideliner further down in the vessel (lm and lad) and subsequently deployed a stent (planned).All devices were removed (no difficulty encountered) and the groin was closed with perclose.The physician performed another angiogram, noticed a clot in the lad and decided to treat with blood thinner (shockwave rep thinks it might be plavix).Patient then coded shortly after and passed away due to the clot and dissection in the proximal lad to lm.The physician reportedly did not know what might have caused the reported event.

• Brand Name: S4 IVL PERIPHERAL CATHETER
• Common Device Name: BALLOON CATHETER
• Manufacturer (Section D): SHOCKWAVE MEDICAL, INC; 5403 betsy ross drive; san jose, ca
• MDR Report Key: 9851053
• Report Number: 3015053858-2020-00005
• Device Sequence Number: 11415841
• Product Code: PPN
• UDI-Device Identifier: M732S4IVL25400
• UDI-Public: M732S4IVL25400
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K180454
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/04/2020

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: 10/31/2021
• Device Model Number: FG63091-2540
• Device Catalogue Number: S4IVL2540
• Device Lot Number: P191026F
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2020
• Initial Report FDA Received Date: 03/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 61 YR