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

Model Number	9336
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Reocclusion (1985)
Date of Event	02/07/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is combination product.
Event or Problem Description
(b)(6) clinical study.It was reported that in-stent restenosis occurred.In (b)(6) 2013, clinical status assessment indicated that the patient's qualifying condition was stable angina and the index procedure was performed.The target lesion #1 was located in the distal left anterior descending artery (lad) with 70% stenosis and was 8.00 mm long with a reference vessel diameter of 2.25 mm.The lesion was treated with pre-dilatation and placement of a 2.25 x 12 mm study stent.Following post dilatation, residual stenosis was noted to be 0% with timi flow 3.The target lesion #2 was located in the mid lad with 90% stenosis and was 14mm long with a reference vessel diameter of 2.25 mm.The lesion was treated with pre-dilatation and placement of a 2.25 x 20 mm study stent.Following post dilatation, residual stenosis was noted to be 0% with timi flow 3.On the next day, the patient was discharged on dual antiplatelet therapy.In (b)(6) 2018, the patient was noted with mild to moderate restenosis at the outlet of the distal left anterior descending study stent.No action was taken in response to the event.

• Brand Name: PROMUS ELEMENT PLUS
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 7812525
• Report Number: 2134265-2018-60320
• Device Sequence Number: 2716727
• Product Code: NIQ
• UDI-Device Identifier: 08714729807759
• UDI-Public: 08714729807759
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: P110010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/24/2018

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: 10/14/2013
• Device Model Number: 9336
• Device Catalogue Number: 9336
• Device Lot Number: 15689423
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2018
• Initial Report FDA Received Date: 08/24/2018
• 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
• Patient Age: 73 YR