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

Model Number A35DC05012013IO

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

Patient Problems Death (1802); Hyperbilirubinemia (1903); Pneumonia (2011); No Code Available (3191); Cancer (3262)

Event Date 05/19/2015

Event Type  Death  

Manufacturer Narrative

The patient's cause of death was unrelated to the study device or procedure.This is being reported as a follow-up to the clinical study.Patient information regarding relevant tests or laboratory data is unknown.This information was not available from the facility.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 u.S.Report source: foreign- (b)(6) / study name: (b)(4).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

It was reported through a clinical study that during the index procedure on (b)(6) 2015, a stellarex catheter was used to treat the target lesion of the left distal sfa.Approximately 29 months post index procedure, it was reported the patient was admitted due to problems with a previous procedure for cholangiocarcinoma.The patient was later diagnosed with gastric outlet obstruction, pneumonia, and hypokalemia.On (b)(6) 2017, a gastrojejunostomy was created.On (b)(6) 2017, the patient expired with high levels of bilirubin and possible evidence of recurrent cholangiocarcinoma.The physician indicated this is not related to the study device or procedure.

• 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: 7027810
• MDR Text Key: 91901809
• Report Number: 3009784280-2017-00067
• 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: 10/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/13/2015
• Device Model Number: A35DC05012013IO
• Device Catalogue Number: A35DC05012013IO
• Device Lot Number: 15A0651202
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/14/2015
• 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: 79 YR
• Patient Weight: 75