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

Model Number	H7493952816250
Medical Device Problem Code	Occlusion Within Device (1423)
Health Effect - Clinical Code	Thrombosis (2100)
Date of Event	09/26/2017
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 from that review, a supplemental medwatch will be filed.(b)(4).
Event or Problem Description
It was reported that stent thrombosis occurred.The target lesions were located in the diagonal and left anterior descending (lad) arteries.A 2.50x16mm promus premier¿ drug-eluting stent was deployed into the diagonal artery and a 3.0mm x 22mm non-bsc stent was deployed in the lad artery.Despite administration of heparin anticoagulant, thrombosis developed in the diagonal artery which was then removed by using a non-bsc aspiration catheter.A 3.0mm x 12mm promus stent was then deployed in the lad artery and the procedure was completed.No further patient complications were reported.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was further reported that the patient was given anti-platelet medication before and during the procedure.Angiography was performed which led to the discovery of thrombosis.A non-bsc stent was also deployed in addition to the 3.0mm x 12mm promus stent that was deployed in the left anterior descending (lad) artery.The patient was also given anti-platelet medication at the time of discharge 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: 6970888
• Report Number: 2134265-2017-10336
• Device Sequence Number: 423310
• Product Code: NIQ
• UDI-Device Identifier: 08714729844716
• UDI-Public: 08714729844716
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 10/03/2017

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: 10/08/2018
• Device Model Number: H7493952816250
• Device Catalogue Number: 39528-1625
• Device Lot Number: 0020537502
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/03/2017
• Supplement Date Received by Manufacturer: 10/25/2017
• Initial Report FDA Received Date: 10/24/2017
• Supplement Report FDA Received Date: 11/09/2017
• 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