MAUDE Adverse Event Report: SPECTRANETICS STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOON; DCB PTA CATHETER

Model Number A35DC06004013IO

Device Problem Insufficient Information (3190)

Patient Problems Pulmonary Embolism (1498); Death (1802)

Event Date 05/11/2015

Event Type  Death  

Manufacturer Narrative

The patient's death was unrelated to the stellarex device or procedure.The patient's death was unrelated to the stellarex device or procedure, thus the paclitaxel drug did not cause or contribute to the patient¿s death.Udi and pma numbers are not applicable.This device was used in clinical application prior to being available in the us.Foreign- belgium / study name: illumenate global, patient id #(b)(6).Combination product is applicable.During the index procedure, the product worked as intended, thus no product evaluation was required.Per the ifu, death is listed as a potential complications/adverse events.

Event Description

On (b)(6) 2015, the patient underwent an index procedure to treat a 120 mm, 80% stenotic denovo lesion in the right distal sfa.The lesion was predilated using a 5 x 80 mm balloon inflated to 8 atm, with a residual stenosis of 10%.Next, a 6 x 120 mm stellarex balloon was inflated to 7 atm for 3 minutes, resulting in 0% stenosis.Then, a 6 x 40 mm stellarex balloon was inflated to 6 atm for 3 minutes, with 0% residual stenosis.No complications occurred and the patient was discharged to go home the following day.The subject completed all required study followup visits through 12 months with the last visit occurring (b)(6) 2016.On (b)(6) 2017, the site became aware that the patient had died (b)(6) 2017.The patient was admitted on (b)(6) 2017.The patient had extensive pulmonary emboli associated with a lung tumor with no treatment options.Initially, the patient was in a relatively good condition as long as oxygen was administered.On (b)(6) 2017, there was a significant respiratory deterioration, for which subcutaneous morphine was administered.The patient died the following day, in the presence of his family.

• Brand Name: STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOON
• Type of Device: DCB PTA CATHETER
• Manufacturer (Section D): SPECTRANETICS; fremont CA
• Manufacturer (Section G): SPECTRANETICS; 6531 dumbarton circle; fremont CA 94555
• Manufacturer Contact: florie cazem ; 5055 brandin court; fremont, CA 94538 ; 510933-792
• MDR Report Key: 6822970
• MDR Text Key: 83728464
• Report Number: 3009784280-2017-00016
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): N
• Reporter Country Code: BE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/07/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 06/22/2015
• Device Model Number: A35DC06004013IO
• Device Catalogue Number: A35DC06004013IO
• Device Lot Number: 14M1760402
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/07/2017
• Initial Date FDA Received: 08/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/24/2014
• 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
• Patient Outcome(s): Other
• Patient Age: 68 YR
• Patient Weight: 94