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

Model Number UNK758

Device Problems Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Myocardial Infarction (1969); Cardiogenic Shock (2262)

Event Date 03/22/2018

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.  (b)(4).The device was not received for analysis.The investigation conclusion is device not returned as the complaint did not include returned device review and lacked the objective evidence or descriptive conditions of the event required to determine what could have contributed to the event.  (b)(4).

Event Description

Same case as mdr id: 2134265-2018-04194.(b)(4) clinical study.It was reported that cardiogenic shock and stent fracture occurred.In (b)(6) 2017, the patient presented emergently with complaints of midsternal chest pain and hypoxia, which improved with medications in the emergency.Physical examination revealed regular rhythm and systolic murmur.The patient was hospitalized for further evaluation and management.At the time of the event, the patient was on baby aspirin and lasix which were continued further.Electrocardiogram (ecg) revealed marked st abnormality due to possible lateral subendocardial injury.Chest x ray revealed elevated right diaphragm.Cardiac enzymes were elevated consistent with protocol definition of myocardial infarction.The patient was diagnosed with non-st segment elevation acute coronary syndrome.The following day, ecg revealed left ventricular hypertrophy with repolarization abnormality and t wave inversion.Three days from hospitalization, selective coronary angiography was performed which revealed 80% stenosis in left main coronary artery (lmca).The lesion was treated with placement of a 3x12mm promus stent and 60% stenosis in proximal left anterior descending artery(lad) which was intervened with a 3x16mm promus stent.Subsequently, retroperitoneal bleeding was noted at the site of coronary catheterization.Drop in hemoglobin level was also observed with acute blood loss anemia.The patient was transfused with 6 units of packed red blood cells ( prbc) post which hemoglobin level was stable.Valve academic research consortium (varc) bleeding classification was life threatening or disabling.Computed tomography scan of abdomen revealed right retroperitoneal hemorrhage measuring approximately 16x3x6cm in size.The vascular event was related to the major bleed retroperitoneal bleed post percutaneous coronary intervention heart catheterization.One day post procedure, excimer laser coronary atherectomy of the lmca was planned.During the procedure, a stent fracture was noted in the lmca due to which the laser catheter (manufacturer unknown) was unable to pass beyond the stent.Furthermore, an angioplasty with angioscope balloon was performed in the mid to distal lmca and the proximal lad.Then, it was finally treated with balloon angioplasty.Subsequently, angiography demonstrated grade iii timi flow.Post stent support angioplasty, the post operative care was complicated and the subject developed cardiogenic shock.The patient was transferred to intensive care unit (icu) for further management and care.Within several days, the patient¿s condition improved; hence, the patient was transferred to the floor.A week after, the bleeding complication and vascular complications were considered to be recovered/ resolved and the patient was discharged home.

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that adjudication indicated myocardial infarction, bleeding complication and vascular complication.

• Brand Name: PROMUS PREMIER¿
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7519136
• MDR Text Key: 108425142
• Report Number: 2134265-2018-04193
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNK758
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 78 YR