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

Model Number H7493925128220

Device Problem Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/09/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: promus premier ous, mr 2.25x28mm, stent delivery system (sds) was returned for analysis.A visual examination of the crimped stent identified damage to strut row's 16 to 20 from the distal end of the stent.The undamaged crimped stent outer diameter (od) was measured which is within the maximum crimped stent profile measurement.It is likely the crimped stent may have encountered resistance & subsequent damage during advancement attempts through the severely tortuous and calcified lesion.A visual examination of the balloon showed that the balloon cones were reviewed and no issues were noted.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.A visual and tactile examination of the device found multiple hypotube kinks noted during analysis.This type of damage is consistent with excessive force being applied to the delivery system.A visual and tactile examination found no issue with the extrusion.The bi-component bond showed no signs of damage or strain.A visual and tactile examination found damage to the tip.No other issues were identified during the product analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).

Event Description

Reportable based on analysis completed on 23-aug-2017.It was reported that shaft kinked occurred.The 90% stenosed, 28x2.25mm target lesion was located in the severely tortuous and severely calcified left circumflex artery (lcx).A 28 x 2.25mm promus premier¿ drug-eluting stent was selected to treat the lesion.However, it was noted that the shaft was kinked.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.However, returned device analysis revealed stent damage.

• 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: 6842989
• MDR Text Key: 84993481
• Report Number: 2134265-2017-08946
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: CN
• PMA/PMN Number: P110010
• 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: 08/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/12/2017
• Device Model Number: H7493925128220
• Device Catalogue Number: 39251-2822
• Device Lot Number: 18952139
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/02/2016
• 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