MAUDE Adverse Event Report: SPECTRANETICS CORPORATION ELCA CORONARY LASER ATHERECTOMY CATHETER; DEVICE, ANGIOPLASTY, LASER, CORONARY

Model Number	110-004
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
From staff: successful tavr [transcatheter aortic valve replacement] procedure, complicated by valve embolization requiring conversion to surgical avr [aortic valve replacement] with placement of a number 23 edwards sapien inspiris valve.From operative report: essentially the valve did not deploy correctly into the aortic annulus and subsequently embolized into the left ventricle.We immediately recognized this and called for backup surgical assistance, perfusion, and all preparation for sternotomy cut down and bailout.Patient remained hemodynamically stable during this time.We elected to leave the sheath and tavr device in the carotid artery which was covered to prevent dislodgement.We made a sternotomy incision and then proceeded to open the pericardium.The patient's act [activated clotting time] was noted to be over 400 seconds from previously administered heparin.Given the relative hemodynamic stability with low pressor requirement, we elected to proceed with central cannulation rather than femoral cannulation for cardiopulmonary bypass.Concentric purse strings were placed in the aorta (at an area free of calcification and plaque) and the right atrium and cannulae were inserted for cardiopulmonary bypass.[redacted], rep with edwards lifesciences, involved and created a complaint [redacted].

• Brand Name: ELCA CORONARY LASER ATHERECTOMY CATHETER
• Common Device Name: DEVICE, ANGIOPLASTY, LASER, CORONARY
• Manufacturer (Section D): SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• MDR Report Key: 22622868
• Report Number: 22622868
• Device Sequence Number: 8345538
• Product Code: LPC
• UDI-Device Identifier: 00813132025458
• UDI-Public: (01)00813132025458
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/10/2025
• Report Date (Section F): 07/10/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 110-004
• Device Catalogue Number: 110-004
• Device Lot Number: 0303384816
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 07/28/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/28/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 81 KG
• Date Report Sent to FDA: 07/10/2025