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

Model Number	H7493952808220
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Anemia (1706); Stroke/CVA (1770); Cardiac Enzyme Elevation (1838); Myocardial Infarction (1969); Cognitive Changes (2551)
Date of Event	04/25/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age at time of event: 18 years or older.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 or Problem Description
Same case as mdr id: 2134265-2017-04952, 2134265-2017-05707, and 2134265-2017-05708.It was reported that myocardial infarction and frontal lobe infarction occurred.The target lesion was located in the left circumflex artery.A 3.00mm x 20mm emerge¿ balloon catheter was advanced for dilatation.The balloon was inflated up to 11 atmospheres; however, the balloon did not hold pressure.Upon removal, the balloon was noted to be ruptured.Angiography was performed and revealed a moderate spiral dissection of the circumflex artery.Subsequently, a 2.25mm x 28mm promus premier¿ drug-eluting stent was advanced but failed to cross the lesion.A 1.5mm x 8mm emerge¿ push balloon catheter was then advanced to re-dilate the artery and a non-bsc guide wire was inserted.A 2.25mm x 8mm promus premier¿ drug-eluting stent was then deployed.A 2.25mm x 20mm promus premier¿ drug-eluting stent was advanced but failed to cross the lesion.This was followed by a 2.5mm x 12mm promus premier¿ drug-eluting stent which was deployed successfully.Lastly, a 2.25mm x 8mm rebel stent was deployed to complete the case.The patient experienced anemia requiring blood transfusion.The patient also suffered a right frontal parietal lobe infarct with subtle cognitive deficit.The patient remained pain free but did bump enzymes the following day.Eight days later, the patient was discharged.

• Brand Name: PROMUS PREMIER¿
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6596330
• Report Number: 2134265-2017-05706
• Device Sequence Number: 1267067
• Product Code: NIQ
• UDI-Device Identifier: 08714729844587
• UDI-Public: (01)08714729844587(17)20180513(10)19998864
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: P110010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/13/2018
• Device Model Number: H7493952808220
• Device Catalogue Number: 39528-0822
• Device Lot Number: 19998864
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2017
• Initial Report FDA Received Date: 05/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention