MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE APEX¿; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number	H7493895940250
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Cardiogenic Shock (2262)
Date of Event	03/07/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.(b)(4).
Event or Problem Description
Same case as mdr id #: 2134265-2018-02588, 2134265-2018-02589, 2134265-2018-02590, 2134265-2018-02592, 2134265-2018-02593, 2134265-2018-02628, 2134265-2018-03162, 2134265-2018-03163, 2134265-2018-03164, 2134265-2018-03165, 2134265-2018-03166, 2134265-2018-03167, 2134265-2018-03168, 2134265-2018-03169, 2134265-2018-03173 it was reported that the patient died post procedure.The patient presented from hospice care.The patient was intubated and had a non-bsc heart pump in place.The target lesions were a chronic total occlusion of the right coronary artery (rca), the left anterior descending artery (lad) and the severely tortuous circumflex.Seventeen boston scientific products were used throughout the procedure.The physician started with the circumflex and experienced a vessel perforation caused by a non-bsc guidewire.The perforation was minimal and was not treated.The lad and left main arteries were successfully stented with 2.50x38mm, 3.00x38mm and 3.50x16mm synergy stents and balloon angioplasty was performed.At that point, the patient¿s pressure and heart rate were both dropping.The heart rate was increased with pacing and the procedure was ended.The patient was sent from the catheterization lab to the floor where he expired some hours later during the night.The cause of death is cardiogenic shock.

• Brand Name: APEX¿
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• MDR Report Key: 7383181
• Report Number: 2134265-2018-02591
• Device Sequence Number: 19246862
• Product Code: LOX
• UDI-Device Identifier: 08714729475927
• UDI-Public: 08714729475927
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P860019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/07/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/15/2021
• Device Model Number: H7493895940250
• Device Catalogue Number: 38959-4025
• Device Lot Number: 21616925
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2018
• Initial Report FDA Received Date: 03/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 76 YR