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

Model Number	H7493911432220
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	02/27/2013
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is a combination product.It is indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.(b)(4).
Event or Problem Description
(b)(4) clinical study.It was reported that jailing occurred.In (b)(6) 2013, the patient was referred for emergent cardiac catheterization.Subsequently, the index procedure was performed.Target lesion #1 was a de novo lesion located in the third obtuse marginal branch (om3) with 95% stenosis and was 30mm long with a reference vessel diameter of 2.25mm.Target lesion #1 was treated with pre-dilatation and placement of a 2.50x32mm promus element¿ plus stent.Following post dilatation, residual stenosis was 0%.After deployment of study stent in om3, jailing was observed in om2 extending up through mid left circumflex artery.It was reported that om2 was jailed approximately with 50% ostial stenosis.Given the complexity of the procedure and the restoration of timi 3 flow post the procedure, no intervention was performed in response to jailing.Target lesion #2 was a de novo long lesion located from proximal left circumflex artery (lcx) to distal lcx with 100% stenosis and was 26mm long with a reference vessel diameter of 2.00mm.Target lesion #2 was treated with direct placement of a 2.25x28mm promus element¿ plus stent with 0% residual stenosis.Target lesion #3 was a de novo long lesion located from proximal left anterior descending artery (lad) to mid lad with 100% stenosis and was 30mm long with a reference vessel diameter of 2.50mm.Target lesion #3 was treated with pre-dilatation and placement of 2.50x32mm and 2.50x32 mm promus element¿ plus study stents.Following post dilatation, residual stenosis was 10%.After four days, the patient was discharged on aspirin and prasugrel.

• Brand Name: PROMUS ELEMENT¿ PLUS
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7382946
• Report Number: 2134265-2018-03180
• Device Sequence Number: 173595
• Product Code: NIQ
• UDI-Device Identifier: 08714729807803
• UDI-Public: 08714729807803
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/01/2018

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: H7493911432220
• Device Catalogue Number: 39114-3222
• Device Lot Number: 0015698394
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2018
• Initial Report FDA Received Date: 03/29/2018
• 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: Other
• Patient Age: 65 YR