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

Model Number H7493911324270

Device Problems Bent (1059); Occlusion Within Device (1423); Device Damaged by Another Device (2915)

Patient Problem Thrombosis (2100)

Event Date 05/12/2018

Event Type  Injury  

Manufacturer Narrative

Age at time of event: 18 years or older.Device is a combination product.(b)(4).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 investigation conclusion is caused by other device as another device/drug/subsequent procedure caused the complaint event.

Event Description

It was reported that stent damage post deployment and thrombosis occurred.The target lesion was located in the left anterior descending (lad) artery.After implanting a 2.5x38 promus element dug-eluting stent (des) in the distal lad, a 2.75x24 mm promus element ¿ des was advanced and successfully deployed in mid lad.During post-dilation, angiography revealed a proximal edge deformation on the 2.75x24 mm promus element ¿ des.Deformation was treated by another post-dilation; however, haziness was observed at the proximal edge.A 3.5x20 mm promus element des was then deployed overlapping the 2.75x24 mm stent and completed the procedure.No further patient complications were reported and the patient's status was stable.

• Brand Name: PROMUS ELEMENT ¿
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7574620
• MDR Text Key: 110275078
• Report Number: 2134265-2018-05045
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: SIMILAR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/15/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 10/29/2018
• Device Model Number: H7493911324270
• Device Catalogue Number: 39113-2427
• Device Lot Number: 20630346
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/15/2018
• Initial Date FDA Received: 06/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/23/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention