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

Model Number	H7493952808220
Medical Device Problem Code	Occlusion Within Device (1423)
Health Effect - Clinical Code	Thrombosis (2100)
Date of Event	09/22/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is a combination product.Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.If there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).
Event or Problem Description
It was reported that stent thrombosis occurred.The target lesion was located in the distal left anterior descending artery (lad).A 2.25 x 8 mm promus premier¿ drug eluting stent was implanted in the target lesion.At the time of the placement, the activated clotting time (act) was 320.Then, when physician was about to work on another lesion, it was noticed that there was a clot forming on the stent.A manual aspiration catheter was then used to remove the clot and the act was 208.The procedure was completed and no further patient complications were reported.The patient has been discharged and was okay.

• Brand Name: PROMUS PREMIER¿
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6952474
• Report Number: 2134265-2017-10249
• Device Sequence Number: 16314302
• Product Code: NIQ
• UDI-Device Identifier: 08714729844587
• UDI-Public: 08714729844587
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/28/2017

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/26/2018
• Device Model Number: H7493952808220
• Device Catalogue Number: 39528-0822
• Device Lot Number: 0020359749
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2017
• Initial Report FDA Received Date: 10/16/2017
• 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