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

Model Number UNK758

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

Patient Problems Non specific EKG/ECG Changes (1817); Cardiac Enzyme Elevation (1838); Fever (1858); Myocardial Infarction (1969); Nausea (1970); Vomiting (2144)

Event Date 03/05/2015

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.Device evaluated by mfr: the complaint device was not returned for analysis.The batch number is unknown and the manufacturing records for the complaint device could not be reviewed.The most probable root cause was unable to be determined.(b)(4).

Event Description

(b)(6).It was reported that myocardial infarction occurred.In (b)(6) 2015, the index procedure was performed.The target lesion was located in the mid left anterior descending (lad) artery with 90% stenosis and was 34 mm long with a reference vessel diameter of 2.75 mm.The target lesion was treated with pre-dilatation and placement of a 2.75 x 38 mm promus premier¿ stent.Post-dilatation was performed with 0% residual stenosis.One day post procedure, the patient was discharged on aspirin and clopidogrel.In (b)(6) 2015, the patient was hospitalized because of nausea, vomiting, diarrhea, and low grade fever.The patient was found to have infectious enteritis and reactive ascites.An electrocardiogram (ecg) showed a nonspecific st and t-wave abnormality and t-wave inversion on the anterior leads.The following day, ecg showed a t-wave abnormality and premature atrial complexes.A transthoracic echocardiogram revealed diffuse disease throughout but no new obstructive lesions, and patent right coronary artery (rca) and lad coronary stents.The patient underwent angiography without revascularization and patency of the coronary stents was confirmed.The location of the non st-segment elevation myocardial infarction (nstemi) was not identified.Four days later, an ecg showed a t-wave abnormality but the premature atrial complexes were no longer present.Seven days from the onset of symptoms, the nstemi was resolved and the patient was discharged.

• 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: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5152249
• MDR Text Key: 28363232
• Report Number: 2134265-2015-04880
• 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
• Report Date: 04/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK758
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/23/2015
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 68 YR