MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-18 for S4 IVL PERIPHERAL CATHETER FG63091-2540 S4IVL2540 manufactured by Shockwave Medical, Inc.
[184032246]
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.
Patient Sequence No: 1, Text Type: N, H10
[184032247]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3015053858-2020-00005 |
| MDR Report Key | 9851053 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-18 |
| Date of Report | 2020-03-04 |
| Date of Event | 2020-03-04 |
| Date Mfgr Received | 2020-03-04 |
| Device Manufacturer Date | 2019-10-26 |
| Date Added to Maude | 2020-03-18 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. ALEXANDRIA MOLINA |
| Manufacturer Street | 5403 BETSY ROSS DRIVE |
| Manufacturer City | SANTA CLARA, |
| Manufacturer Country | US |
| Manufacturer G1 | SHOCKWAVE MEDICAL, INC |
| Manufacturer Street | 5403 BETSY ROSS DRIVE |
| Manufacturer City | SANTA CLARA, |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | S4 IVL PERIPHERAL CATHETER |
| Generic Name | BALLOON CATHETER |
| Product Code | PPN |
| Date Received | 2020-03-18 |
| Model Number | FG63091-2540 |
| Catalog Number | S4IVL2540 |
| Lot Number | P191026F |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SHOCKWAVE MEDICAL, INC |
| Manufacturer Address | 5403 BETSY ROSS DRIVE SAN JOSE, CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2020-03-18 |