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

Model Number	H7493952820250
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	02/20/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is a combination product.(b)(4).Device evaluated by mfr: the complaint device was not returned for analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable cause of the reported difficulties may be due interaction with another device.(b)(4).
Event or Problem Description
It was reported that plaque shift and stent fracture occurred.The target lesion was located in a saphenous vein graft in the obtuse marginal branch.After a.075 non-bsc guide catheter was engaged and a non-bsc guide wire crossed the lesion, a 2.50x23mm stent was deployed to cover the proximal lesion that extended to the ostium.The distal lesion was then pre-dilated with a 2.0x15mm non-compliant balloon catheter and a 2.50x20mm promus premier¿ drug-eluting stent was deployed where there was in-stent restenosis in a previously implanted stent.However, the physician noted some plaque shift proximal to the stent, so a 2.50x16mm promus premier¿ drug-eluting stent was deployed to overlap the 2.50x20mm promus premier¿ stent.Subsequently, the two promus premier¿ stents were post-dilated with a 3.0x15mm non-compliant balloon catheter and the proximal ostial stent was post-dilated with a 3.0x20mm and 3.50x12mm non-compliant balloon catheters with good results.After post-dilatation, the physician noted an acute stent fracture of the 2.50x20mm promus premier¿ stent.The physician attempted to stent jail the segment with a 2.50x18mm non-bsc stent but it was unable to cross the lesion.There was timi 3 flow in the vessel, so the physician decided to medically manage the patient and the procedure was completed.No further patient complications were reported and the patient's status was stable.

• Brand Name: PROMUS PREMIER¿
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6404405
• Report Number: 2134265-2017-01867
• Device Sequence Number: 10995992
• Product Code: NIQ
• UDI-Device Identifier: 08714729844778
• UDI-Public: (01)08714729844778(17)20180408(10)19855520
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 02/20/2017

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: 04/08/2018
• Device Model Number: H7493952820250
• Device Catalogue Number: 39528-2025
• Device Lot Number: 19855520
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2017
• Initial Report FDA Received Date: 03/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 2.5/16MM PROMUS PREMIER STENT; 3.0/15MM NC BALLOON CATHETER; AL .075 GUIDE CATHETER; WHISPER EXTRA SUPPORT GUIDE WIRE
• Outcome Attributed to Adverse Event: Required Intervention