MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION SPECTRANETICS TURBO-POWER LASER ATHERECTOMY CATHETER; CATHETER, PERIPHERAL, ATHERECTOMY

Model Number 423-050

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

Patient Problems Restenosis (4576); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/23/2022

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: the therapy date is recorded as (b)(6) 2022, the date of the initial procedure.Device evaluated by mfr: the device was discarded, thus no investigation could be completed.Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorized representative or the national competent authority that the content of this report is complete or accurate, that the medical device(s) listed failed in any manner and/or that the medical device(s) caused or contributed to an alleged death or deterioration in the state of the health of any person.

Event Description

A peripheral atherectomy procedure commenced on (b)(6) 2022 to treat a severely calcified lesion in the patient's left proximal superficial femoral artery (sfa).A stent had been placed in this area prior to the procedure, and the patient was experiencing a wound and numbness in the left lower extremity.The physician chose a spectranetics turbo-power laser atherectomy catheter to treat the patient, followed by balloon therapy, and the procedure was successfully completed.Following the initial procedure, the patient was treated with antimicrobials and anticoagulants.However, some numbness remained after the procedure, so the patient was checked daily by doppler ultrasonography and palpation.Over the next few days, testing showed a decreased left ankle/brachial index (abi) which can indicate worsening peripheral artery disease (pad).On (b)(6) 2022, an echo was performed and the following day, the physician diagnosed an in-stent restenosis (isr) in the same region treated initially.On(b)(6) 2022, a procedure commenced to treat the isr, using a turbo-power, a plain old balloon angioplasty (poba), and a stent graft.The procedure was successfully completed with no reported patient harm.The physician was unsure of the cause, but believed the initial procedure and the subsequent isr may be causally related.This report is being submitted to capture the turbo-power device used in the (b)(6) 2022 procedure, in which in-stent restenosis occurred <30 days from the initial procedure, requiring intervention.There was no alleged malfunction of any spectranetics devices in use during the 11 july and 25 july procedures.

Manufacturer Narrative

B5/h2): this event is no longer reportable.G3): complaint re-evaluation was completed 11jan2023.H6): based on physician clinical assessment, reocclusion or in-stent restenosis is not a function of any intraluminal diagnostic or therapeutic device but rather a progression of the underlying pathophysiologic disease process.H6 codes submitted on the initial mdr are no longer applicable and updated with: hecc code 4582 replaces 4576; heic code 2199 replaces 4624 and 4621.Investigation conclusions code 67 replaces 4311.Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorized representative or the national competent authority that the content of this report is complete or accurate, that the medical device(s) listed failed in any manner and/or that the medical device(s) caused or contributed to an alleged death or deterioration in the state of the health of any person.

Event Description

This event is no longer reportable for the turbo-power device creating or contributing to the in-stent restenosis.After complaint re-evaluation and physician clinical assessment, it was determined the in-stent restenosis was not device related.

• Brand Name: SPECTRANETICS TURBO-POWER LASER ATHERECTOMY CATHETER
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921
• MDR Report Key: 15332257
• MDR Text Key: 299043013
• Report Number: 1721279-2022-00163
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 00813132026776
• UDI-Public: (01)00813132026776(17)240523(10)FMP22E06A
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K180694
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 423-050
• Device Catalogue Number: 423-050
• Device Lot Number: FMP22E06A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2022
• 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
• Treatment: ABBOTT SUPERA STENT SYSTEM; BALLOON THERAPY (SABERX NSE IN.PACT ADMIRAL); BOSTON SCIENTIFIC ELUVIA DRUG ELUDING STENT; GORE VIABAHN ENDOPROSTHESIS; GUIDE CATHETER MANUFACTURER AND SIZE UNK; GUIDE WIRE MANUFACTURER AND SIZE UNK; INTRODUCER SHEATH MANUFACTURER AND SIZE UNK; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 57 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian