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

Model Number	H7493952832350
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.Device evaluated by mfr.: the device was not returned for analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The root cause is anticipated procedural complications as this event is a known physiological effect of the procedure and is noted within the dfu.(b)(4).
Event or Problem Description
It was reported that stent thrombosis occurred.The target lesion was located in the mid left anterior descending (lad) artery.A 3.50 x 32 mm promus premier¿ drug-eluting stent was deployed into the lesion; however, thrombosis developed despite administration of heparin anticoagulant.No further patient complications were reported.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was further reported that angiography was performed which led to the discovery of thrombosis.A non-bsc stent was deployed in the mid left anterior descending (lad) artery and another promus stent was deployed in the diagonal branch.The intervention was successful 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: 6976354
• Report Number: 2134265-2017-10331
• Device Sequence Number: 11130160
• Product Code: NIQ
• UDI-Device Identifier: 08714729844983
• UDI-Public: 08714729844983
• 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: Other
• 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: 09/16/2018
• Device Model Number: H7493952832350
• Device Catalogue Number: 39528-3235
• Device Lot Number: 0020455385
• 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: 10/25/2017
• Supplement Report FDA Received Date: 11/08/2017
• 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