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

Model Number	H7493911428270
Medical Device Problem Code	Occlusion Within Device (1423)
Health Effect - Clinical Codes	Angina (1710); Reocclusion (1985)
Date of Event	10/23/2012
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is a combination product.The complaint device was not received for analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The root cause is anticipated procedural complications as this event is a known physiological effect of the procedure and is noted within the dfu.(b)(4).
Event or Problem Description
(b)(4) clinical study.It was reported that in-stent restenosis (isr) occurred.In (b)(6) 2012, the patient was referred for cardiac catheterization.Subsequently, index procedure was performed.The target lesion #1 was a de novo lesion located in first diagonal branch with 90% stenosis and was 20mm long with a reference vessel diameter of 2.25mm.The lesion was treated with pre-dilatation and placement of 2.25x28mm promus element¿ plus drug-eluting stent.Following post-dilatation, residual stenosis was 0%.The target lesion #2 was a de novo lesion located in the proximal left anterior descending (lad) artery with 60% stenosis and was 20mm long with a reference vessel diameter of 2.75mm.The lesion was treated with pre-dilatation and placement of a 2.75x28mm promus element¿ plus drug-eluting stent.Following post-dilatation, the residual stenosis was 0%.One day post procedure, the patient was discharged on aspirin and clopidogrel.In (b)(6) 2012, the patient was hospitalized for staged percutaneous coronary intervention (pci) of the left circumflex (lcx) and proximal lad.Patient¿s coronary angiography revealed with 80% proximal stenosis.Subsequently, the 80% isr at the proximal lad was treated with balloon angioplasty with 0% residual stenosis.Additionally on the same day, pci of the left lcx was performed (non-target vessel revascularization).Four days post admission, the event was considered as resolved and the patient was discharged on the same day.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was further reported that in (b)(6) 2012, the patient presented due to coronary artery disease and diagnosed with class iv angina.The patient was scheduled for stage percutaneous coronary intervention (pci).During ventricular cineangiography, the patient developed ventricular asystole with ¿p waves marching¿ which required temporary pacemaker insertion and medical therapy.The isr of the proximal lad was treated with cutting balloon angioplasty.Decision was made not to proceed with pci of obtuse marginal (om) branch distal to pre-existing unknown stent due to the small nature of the distal vessel.The patient was discharged on aspirin and clopidogrel.

• Brand Name: PROMUS ELEMENT¿ PLUS
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• MDR Report Key: 6798598
• Report Number: 2134265-2017-08493
• Device Sequence Number: 13666892
• Product Code: NIQ
• UDI-Device Identifier: 08714729807926
• UDI-Public: (01)08714729807926(17)20130506(10)0015311499
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P110010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2017

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/06/2013
• Device Model Number: H7493911428270
• Device Catalogue Number: 39114-2827
• Device Lot Number: 0015311499
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/04/2017
• Supplement Date Received by Manufacturer: 08/16/2017
• Initial Report FDA Received Date: 08/16/2017
• Supplement Report FDA Received Date: 08/28/2017
• 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: Hospitalization; Required Intervention
• Patient Age: 81 YR