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

Model Number H7493911324300

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

Patient Problems Death (1802); Low Blood Pressure/ Hypotension (1914); Ischemia (1942); Nausea (1970); Ventricular Fibrillation (2130); Vomiting (2144); Numbness (2415); Sweating (2444)

Event Date 12/22/2014

Event Type  Death  

Manufacturer Narrative

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).

Event Description

Pe-prove clinical study it was reported that the patient died.In (b)(6) 2010, the patient presented due to unstable angina and was referred for cardiac catheterization which revealed an 85% stenosed, de-novo lesion located in the proximal left circumflex (lcx) artery and extending into the distal lcx and was 20 mm long with a reference vessel diameter of 3.00 mm.The lesion was treated with pre-dilatation and placement of a 3.00x24mm promus element stent, with 0% residual stenosis.The following day, the patient was discharged on aspirin and clopidogrel.In (b)(6) 2014, the patient died.The cause of death is not known at the time of this report.

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that post stent implantation with a 3.00x24mm promus element stent, post dilation was performed with kissing balloon technique resulting to 0% residual stenosis.In (b)(6) 2014, the patient presented with recurrent chest pain and was hospitalized on the same day.Electrocardiogram (ecg) revealed symptoms of inferoposterior myocardial infarction(mi).Cardiac enzymes were not drawn; however, coronary angiography was performed which revealed 100% in-stent restenosis from the left main coronary artery extending to the proximal left circumflex artery (lcx) with occluded distal lcx.On the same day, the 100% totally occluded in-stent restenosis in the proximal lcx extending to the distal lcx was treated with balloon angioplasty and mechanical external compression using autopulse.However, the patient became asystolic.

Manufacturer Narrative

Describe event or problem updated.(b)(4).

Event Description

It was further reported that post stent implantation with a 3.00x24mm promus element stent, only post-dilatation was done and not with kissing balloon technique as previously reported.

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that in (b)(6) 2010, during the index procedure, stenosis of the 1st obtuse marginal (om) was treated with dilatation using 2x15mm apex balloon catheter.Following this, the tight bifurcated lesion of left circumflex artery (lcx) was treated with pre dilatation using the same apex balloon.However, the balloon failed to expand completely in the middle section.As a result, following study stent placement , the target lesion was post dilated with 8x3.5mm quantum balloon catheter.In (b)(6) 2014, the patient was presented with severe chest pain arising from right lower limb.Also the patient experienced sweating, nausea, vomiting, hypotension, numbness, agitation and was uncooperative and the patient was hospitalized on same day.The pain didn't reduce even after administration of morphine.Further little improvement was noticed after administration of atropine and iv fluids.Agitation didn't reduce even after giving morphine and diazemuls.Therefore the patient was sedated and incubated.Also adrenaline was given.The right ventricle was paced, adrenaline bolus was given, ventricular fibrillation arrests were treated with shocks and also mechanical external compression was given using autopulse.Electrocardiogram (ecg) was performed and the patient experienced recurring chest pain and ischemic symptoms were also observed.Subsequently, the patient was diagnosed with ventricular fibrillation.On the same day, the 100% stenosis in distal lcx extending to left posterior descending artery (l-pda) was treated with balloon angioplasty with 20% residual stenosis.Further ventricular fibrillation/ asystole and pacing wire was no longer capturing.So shocks were delivered and various cardiac arrest drugs were given but still no pacing was captured despite of changing wire position.Finally, the procedure was stopped and the event was considered to be resolved without residual effects and the patient was discharged on the same day.

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that the ventricular fibrillation (vf) asystole was noted and pacing wire was no longer capturing, two shocks were delivered still no pacing was captured despite of changing wire position.Finally, the procedure, was stopped.In (b)(6) 2014, the patient became asystolic and with no blood pressure (bp) and pronounced as dead.The patient died due to acute inferoposterior myocardial infarction.Death certificate and autopsy are not available.

• Brand Name: PROMUS ELEMENT ¿
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5001736
• MDR Text Key: 22937784
• Report Number: 2134265-2015-05861
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: SIMILAR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Followup,Followup,Followup,Followup
• Report Date: 08/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/22/2011
• Device Model Number: H7493911324300
• Device Catalogue Number: 39113-2430
• Device Lot Number: 12894848
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/19/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 66 YR