EMERGE

Report

Report Number: 2134265-2014-05787
Event Type: Injury
Date Received: September 19, 2014
Date of Event: August 21, 2014
Report Date: September 1, 2014
Manufacturer: BOSTON SCIENTIFIC - MAPLE GROVE
Product Code: LOX
PMA / PMN Number: K113220
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: MO, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

DEVICE EVALUATED BY MFR.: THE COMPLAINT DEVICE WAS NOT RECEIVED FOR ANALYSIS. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. 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).

Description of Event or Problem · 1

SAME CASE AS MDR ID# 2134265-2014-05778, 2134265-2014-05779, 2134265-2014-05780, 2134265-2014-05785, 2134265-2014-05786, 2134265-2014-05788, 2134265-2014-05789, 2134265-2014-05790. (B)(4). IT WAS REPORTED THAT THROMBOSIS OCCURRED. ON (B)(6) 2014, THE PATIENT WAS PRESENTED WITH COMPLAINTS OF SUDDEN ONSET OF CHEST PAIN AND WAS HOSPITALIZED ON THE SAME DAY. ELECTROCARDIOGRAM (ECG) REVEALED ST ELEVATION IN INFERIOR AND LATERAL LEADS AND NONSPECIFIC INTRAVENTRICULAR BLOCK. THE PATIENT WAS THEN DIAGNOSED WITH ACUTE Q-WAVE INFEROLATERAL WALL STEMI AND CARDIAC CATHETERIZATION WAS RECOMMENDED. AT THE TIME OF EVENT, THE PATIENT WAS TAKING ASPIRIN AND CLOPIDOGREL AND THE STUDY DRUG PROTOCOL WAS LAST TAKEN ON (B)(6) 2012. CORONARY ANGIOGRAPHY WAS REVEALED ACUTE THROMBOTIC OCCLUSION IN OM1 OF THE 2.75 X 12 MM TAXUS® LIBERTÉ® STENT AND 2.50 X 12 MM NON-STUDY TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM; AND ACUTE THROMBOTIC OCCLUSION OF THE 2.75 X 38 MM TAXUS® LIBERTÉ® STENT AND TWO (2.5 X 24 PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM) STENTS IMPLANTED IN (B)(6) 2012 IN DISTAL LEFT CIRCUMFLEX (LCX).THE 100% STENOSIS IN OBTUSE MARGINAL (OM1) WAS TREATED WITH THROMBECTOMY FOLLOWING WHICH BALLOON INFLATIONS WERE DONE USING A 2.50 X 20 MM EMERGE BALLOON CATHETER. A 3.5 RUNWAY GUIDE CATHETER AND A CHOICE GUIDEWIRE WERE PASSED INTO OM1, SUBSEQUENTLY RE-THROMBOSIS OF OM1 WAS NOTED AND WAS EVENTUALLY TREATED WITH THROMBECTOMY RESULTING IN 0% RESIDUAL STENOSIS. IN ADDITION, THE OSTIUM OF THE OM2 WAS SEEN TO BE HAZY WITH 100% STENOSIS IN OM2 WHICH WAS TREATED WITH BALLOON ANGIOPLASTY WITH 0% RESIDUAL STENOSIS. THE 90% STENOSIS IN DISTAL LCX WAS ALSO TREATED WITH BALLOON ANGIOPLASTY AND PLACEMENT OF A 2.75 X 24 MM PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM, HOWEVER FOLLOWING DEPLOYMENT,SPASM O THROMBUS IN OM3 WAS NOTED. THE 100% STENOSIS IN OM3 ALONG WITH SPASM/THROMBUS WAS TREATED WITH BALLOON ANGIOPLASTY, RESULTING IN 0% RESIDUAL STENOSIS. THE PATIENT WAS TRANSFERRED TO INTENSIVE CARE UNIT (ICU) WHERE THE RE-OCCLUSION OF THE CIRCUMFLEX OM SYSTEM WAS NOTED WHICH WAS TREATED WITH ASPIRATION THROMBECTOMY. THE 90% STENOSIS IN DISTAL LCX EXTENDING UP TO OM2 WAS TREATED WITH KISSING BALLOON ANGIOPLASTY AND PLACEMENT OF TWO 2.5 X 16 MM DRUG ELUTING PROMUS PREMIER STENTS WHICH WERE DEPLOYED IN A KISSING TECHNIQUE FROM THE MID TO DISTAL CIRCUMFLEX AND OM2. IN ADDITION MILD HAZINESS WAS NOTED BEYOND OM2. THE 90% STENOSIS, WITH HAZINESS, IN DISTAL LCX WAS TREATED WITH BALLOON ANGIOPLASTY AND PLACEMENT OF 2.25 X 12 MM PROMUS STENT AND THE 90% STENOSIS IN PROXIMAL LCX WAS TREATED WITH BALLOON ANGIOPLASTY. FOLLOWING POST-DILATION, RESIDUAL STENOSIS WAS 0%.THREE DAYS POST PROCEDURE, THE EVENT WAS CONSIDERED TO BE RESOLVED WITHOUT RESIDUAL EFFECTS AND THE PATIENT WAS DISCHARGED ON THE SAME DAY ON ASPIRIN AND BRILINTA WITH RECOMMENDATION OF FOLLOW UP AFTER ONE WEEK.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
582114	EMERGE	CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS	LOX	BOSTON SCIENTIFIC - MAPLE GROVE	UNK731

Patients

Seq	Age	Sex	Outcome	Treatment
1	64 YR		Required Intervention