PROMUS ELEMENT ¿

Report

Report Number: 2134265-2012-06859
Event Type: Injury
Date Received: November 15, 2012
Date of Event: July 31, 2012
Report Date: October 17, 2012
Manufacturer: BOSTON SCIENTIFIC - GALWAY
Product Code: NIQ
PMA / PMN Number: SIMILAR
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(6). DATE OF BIRTH: (B)(6) 1950. DEVICE IS COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: 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).

Additional Manufacturer Narrative · 1

(B)(4).

Description of Event or Problem · 1

IT WAS FURTHER REPORTED THAT IN (B)(6) 2012, THE IN-STENT STENOSIS LOCATED IN THE PROXIMAL LEFT CIRCUMFLEX ARTERY (LCX) EXTENDING INTO THE 1ST OBTUSE MARGINAL WAS TREATED WITH BALLOON ANGIOPLASTY USING A 3.0 MM X 20 MM NON-BSC DRUG ELUTING BALLOON RESULTING IN GOOD FLOW INTO THE PERIPHERY. ADDITIONALLY, THE 100% STENOSIS LOCATED IN THE 1ST LEFT POSTEROLATERAL BRANCH (LPL) WAS TREATED WITH BALLOON ANGIOPLASTY. IN (B)(6) 2012, THE 90% STENOSIS LOCATED IN THE 1ST OBTUSE MARGINAL (OM) WAS TREATED WITH BALLOON ANGIOPLASTY WITH THE PLACEMENT OF A 2.25 MM X 28 MM PROMUS ELEMENT DRUG ELUTING STENT AND SUBSEQUENTLY A 2.5 MM X 28 MM NON-BSC DRUG ELUTING STENT IS DEPLOYED IN THE SAME LOCATION. ADDITIONALLY, THE 90% STENOSIS LOCATED IN THE 1ST LPL WAS TREATED WITH DIRECT PLACEMENT OF DRUG ELUTING STENT WITH 0% RESIDUAL STENOSIS. IN ADDITION, A NON-TARGET VESSEL REVASCULARIZATION WAS ALSO PERFORMED IN RIGHT CORONARY ARTERY (RCA) WHICH WAS TREATED USING A 2.5 X 28 MM NON-BSC DRUG ELUTING STENT, RESULTING IN FLOW IMPROVEMENT.

Description of Event or Problem · 1

(B)(4). SAME CASE AS MDR ID 2134265-2012-06860. IT WAS REPORTED THAT AFTER A PERCUTANEOUS CORONARY INTERVENTION (PCI) STENTING TREATMENT PROCEDURE, THE PATIENT EXPERIENCED A MYOCARDIAL INFARCTION AND RESTENOSIS. THE TARGET LESION #1 WAS A LONG BIFURCATED LESION LOCATED IN THE 1ST OBTUSE MARGINAL (OM) WITH 100% STENOSIS AND WAS 72 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.00 MM. THE TARGET LESION #1 WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A PROXIMALLY OVERLAPPING 2.50 MM X 16 MM AND 3.00 MM X 32 MM PROMUS ELEMENT STENTS AND ADDITIONALLY THE TARGET LESION WAS TREATED WITH A NON STUDY STENT, WITH 0% RESIDUAL STENOSIS. DURING THE INDEX PROCEDURE, THE SUBJECT HAD A NON-TARGET LESION LOCATED IN THE PROXIMAL LEFT CIRCUMFLEX ARTERY (LCX) WHICH WAS TREATED WITH THE PLACEMENT OF A DRUG ELUTING STENT. THE SUBJECT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2012, THE SUBJECT EXPERIENCED ELEVATED CREATININE KINASE (CK) AND AN EVENT OF MYOCARDIAL INFARCTION WAS REPORTED. 100% IN-STENT RESTENOSIS LOCATED IN THE PROXIMAL LCX AND EXTENDING INTO THE 1ST OM WAS TREATED WITH PCI WITH 0% RESIDUAL STENOSIS. AN ELECTROCARDIOGRAM WAS PERFORMED. IT WAS NOTED THAT THE SUBJECT DID NOT EXPERIENCE ISCHEMIC SYMPTOMS AND NO OTHER ACTION WAS TAKEN TO TREAT THIS EVENT. THE EVENT WAS CONSIDERED RESOLVED WITHOUT RESIDUAL EFFECTS. IN (B)(6) 2012, THE SUBJECT PRESENTED WITH RECURRENT CARDIAC DECOMPENSATIONS. THE 90% STENOSIS LOCATED IN THE 1ST OM WAS TREATED WITH PLACEMENT OF DRUG ELUTING STENT, WITH 0% RESIDUAL STENOSIS. ADDITIONALLY, A NON-TARGET VESSEL REVASCULARIZATION WAS ALSO PERFORMED. THE SUBJECT WAS ALSO TREATED WITH IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) IMPLANTATION. IN (B)(6) 2012, THE SUBJECT UNDERWENT AORTIC VALVE REPLACEMENT. IN (B)(6) 2012, THE EVENT WAS CONSIDERED RESOLVED WITHOUT RESIDUAL EFFECTS AND THE SUBJECT WAS DISCHARGED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	PROMUS ELEMENT ¿	STENT, CORONARY, DRUG-ELUTING	NIQ	BOSTON SCIENTIFIC - GALWAY	H7493911332300	13654456

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention