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

Model Number	H7493952828270
Medical Device Problem Codes	Bent (1059); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/18/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).Device is a combination product.(b)(4).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 med watch will be filed.(b)(4).
Event or Problem Description
It was reported that stent damage occurred.The target lesion was located in the left anterior descending (lad) artery.During a two-vessels percutaneous coronary intervention (pci), a stent was successfully deployed in the circumflex (lcx) artery.A 2.75x28mm promus premier¿ drug eluting stent was advanced over a non-bsc guide wire and was successfully implanted.However, when the guide wire was removed, it was noted that the distal portion of the stent had double density appearance which may have been caused by the non-bsc guidewire getting wrapped around the stent struts causing distal deformation.The stent was re-wired and a 2.75 promus drug eluting stent was advanced distally to cover up the portion of deformation.No further patient complications were reported.The patient was doing well and was discharged the following day.

• Brand Name: PROMUS PREMIER¿
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6314094
• Report Number: 2134265-2017-00821
• Device Sequence Number: 18842358
• Product Code: NIQ
• UDI-Device Identifier: 08714729844907
• UDI-Public: (01)08714729844907(17)20171210(10)19385227
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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): 01/23/2017

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: 12/10/2017
• Device Model Number: H7493952828270
• Device Catalogue Number: 39528-2827
• Device Lot Number: 19385227
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2017
• Initial Report FDA Received Date: 02/09/2017
• 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
• Patient Age: 75 YR