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

Model Number H7493912408400

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

Patient Problem Death (1802)

Event Date 12/13/2016

Event Type  Death  

Manufacturer Narrative

Device evaluated by mfr: the device was not received for analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The root cause is anticipated procedural complications as this event is a known physiological effect of the procedure and is noted within the dfu.(b)(4).

Event Description

Same case as mdr id: 2134265-2016-12261, 2134265-2016-12258, 2134265-2016-12260, 2134265-2016-12257, 2134265-2016-12256.It was reported that the patient died.Several days prior to this percutaneous coronary intervention (pci), this patient had a repeat thoracic endovascular aneurysm repair (tevar) for a dissection in the aorta.A stent graft was placed at that time.Open surgery was not an option for this pci due to the patient¿s condition.Vascular access was obtained via the femoral artery.The target lesions were located in the distal left main to proximal left anterior descending (lad) and mid lad arteries; the disease was noted to be complex.During the procedure an opticross¿ imaging catheter, a samurai guidewire, a 2.00mmx20mm emerge¿ balloon catheter and a 8mmx4.00mm nc quantum apex¿ balloon catheter were used.A 2.25x28 synergy ii drug-eluting stent (des) was deployed in the mid lad and a 3.50 x 16 synergy ii des was deployed in the distal left main to proximal lad.The procedure went very well.However, as staff was undraping the patient and preparing to transfer, the patient began to bleed internally through his chest tube.Surgery and anesthesia were called and they worked on him, but they could not stop the bleeding and he expired within 10-15 minutes of that time.The physician believes that the patient¿s aorta ruptured and they likely bled out due to that and the anticoagulants.Angiomax was used during the procedure.

• Brand Name: NC QUANTUM APEX¿
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6243726
• MDR Text Key: 64548187
• Report Number: 2134265-2016-12259
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121667
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Model Number: H7493912408400
• Device Catalogue Number: 39124-0840
• Device Lot Number: 19879224
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2016
• 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: BALLOON: EMERGE 2.00MM X 20MM; GUIDEWIRE: SAMURAI 190CM, STRAIGHT TIP; IVUS CATHETER: OPTICROSS; STENT: SYNERGY II 2.25 X 28; STENT: SYNERGY II 3.50 X 16
• Patient Outcome(s): Death
• Patient Age: 79 YR