MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY PROMUS PREMIER¿; STENT, CORONARY, DRUG-ELUTING

Model Number H7493952824270

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

Patient Problems Intimal Dissection (1333); Death (1802); Ventricular Tachycardia (2132)

Event Date 05/18/2015

Event Type  Death  

Event Description

(b)(6).It was reported that death, ventricular tachycardia and hypokalemia occurred.In (b)(6) 2015, the index procedure was performed.The target lesion was located in the proximal circumflex with 75% stenosis and was 16mm long with a reference vessel diameter of 2.8mm.The target lesion was treated with pre-dilatation and a 2.75x24 mm promus premier stent.Post-dilatation was performed with 0% residual stenosis.The following day, the patient was discharged on aspirin and clopidogrel.Twelve days post procedure, the patient presented with five implantable cardioverter defibrillator (icd) shocks with no prior chest pain or warnings.While having the icd interrogated, the patient received a 6th shock.The interrogation revealed that the shocks were appropriate for ventricular tachycardia (vt) and not a device malfunction.The patient was treated with amiodarone 150mg intravenous (iv) and admitted to the cardiovascular intensive care unit (cvicu) for further monitoring.The following day, a cardiac catheterization revealed 100% ostial left anterior descending (lad) lesion, 100% stenosed proximal lad lesion, 100% stenosed left circumflex with widely patent stent and ostial 1st marginal lesion.The most likely cause of the vt was hypokalemia with a potassium level of 2.8 meq/l.Two days after, the patient was discharged in hemodynamically stable condition.In (b)(6) 2015, the patient presented with two icd shocks for vt and syncopal episodes and was admitted.Electrophysiology (ep) interrogated the patient's icd which revealed appropriate shocks for vt.The patient was treated with increased mexiletine dose, but continued to have recurrent episodes of symptomatic non-sustained vt.Ep consultation recommended vt ablation.Seven days after, the patient experienced vt and underwent vt ablation.Prior to the ablation procedure, the patient's icd was interrogated and showed normal function; the icd¿s tachy therapies and shocks were turned off for the duration of the procedure.The patient had an intrinsic sinus rhythm with left bundle branch block (lbbb); the biventricular (biv) pacing therapies were turned off for vt mapping.In pre-ablation, the patient had several spontaneous runs of non-sustained and also sustained vt.The patient's vt was also easily inducible with single ventricular extra stimuli and catheter manipulation.More than one morphology of vt was noticed.The predominant vt morphology was right bundle branch block (rbbb)/inferior axis/precordial transition v 4, cycle length 310 ms.An impella left ventricular assist device (lvad) was placed, and the patient's biv pacing therapy was turned on.Forty nine ablation lesions were delivered.The patient received 43 external shocks for spontaneous/catheter induced vt during the procedure.After the procedure, neither spontaneous nor catheter-induced vt was noticed.No attempts were made to induce vt.The patient was transferred to the cvicu with the lvad in place and mechanically ventilated.The patient was hemodynamically stable with mean bp 70-80 mmhg.In the cvicu, the patient's icd was re-interrogated and normal function was confirmed; the icd¿s tachy therapies were turned on.The patient remained on lvad support and was treated with dobutamine and norepinephrine until the morning.Two days after, the patient experienced vt arrest and cpr was started.All together, the patient received 11 rounds of epinephrine and two rounds of amiodarone.The patient's vt arrest progressed to pulseless electrical activity arrest.Intra-aortic balloon pump was placed and the patient was pronounced dead.The primary cause of death was listed as ventricular tachycardia, with ischemic cardiomyopathy and recurrent vt.No postmortem examination was performed.

Manufacturer Narrative

(b)(4).Device is a combination product.Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted.If there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that there was grade b dissection at the index procedure that required no intervention.The most severe dissection was distal to the target lesion.The cause of the dissection was the insertion of the study stent.

• Brand Name: PROMUS PREMIER¿
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY; ballybrit business park; galway
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY; ballybrit business park; galway
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 4893725
• MDR Text Key: 19814039
• Report Number: 2134265-2015-04295
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative,company representati
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2016
• Device Model Number: H7493952824270
• Device Catalogue Number: 39528-2427
• Device Lot Number: 17579852
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/06/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 56 YR