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

Model Number UNK758

Device Problems Migration or Expulsion of Device (1395); Difficult to Remove (1528); Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Jin, uram, et.Al., 'longitudinal stent-strut injury at the distal end of a newer-generation drug-eluting stent', korean circ j 2018 feb;8(2):176-178.Device is a combination product.(b)(4).Device evaluated by mfr: the device was not returned for analysis.The investigation conclusion is caused by other device as another device/drug/subsequent procedure caused the complaint event.(b)(4).

Event Description

It was reported via literature that stent damage, prolapse and difficult removing occurred.Coronary angiography revealed total occlusion of the left anterior descending coronary artery (lad) ostium and intermediate stenosis of the proximal left circumflex artery (lcx).After stenting with a 3.5×38-mm non-bsc stent from the left main (lm) to the lad, t-stenting was attempted with a 2.75×18-mm promus premier¿ stent in the compromised lcx ostium.Despite repeated pre-dilation and kissing balloon inflation at the lm bifurcation, the stent failed to cross the lcx ostium and its distal tip became stuck.After removing the whole stent system, prolapse and deformation of the distal struts were noted.A 2.5×14-mm non-bsc stent was chosen instead and successfully deployed.

• Brand Name: PROMUS PREMIER¿
• 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: 7755323
• MDR Text Key: 116224914
• Report Number: 2134265-2018-06903
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: KR
• PMA/PMN Number: P110010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNK758
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 86