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

Model Number H7493911324270

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/06/2017

Event Type  malfunction  

Manufacturer Narrative

Device is a combination product.(b)(4).

Event Description

It was reported that stent damage occurred.The over 90% stenosed target lesion was located in the left circumflex artery.A 2.75x24mm promus element¿ drug-eluting stent was advanced but failed to cross the lesion.During withdrawal, it was noted that the stent strut was lifted up.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.

Manufacturer Narrative

Device evaluated by mfr.: the stent delivery system was returned for analysis.A visual examination of the stent found that the first distal stent row was damaged with a stent strut lifted.The undamaged crimped stent outer diameter was measured and was within maximum crimped stent profile measurement.A visual and microscopic examination of the bumper tip found no signs of damage.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 no issues along the hypotube.A visual and tactile examination of the device found that there were no issues with the mid shaft, inner or outer polymer extrusion.No other issues were identified during the product analysis.The investigation conclusion is operational context as the product meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).

Event Description

It was reported that stent damage occurred.The over 90% stenosed target lesion was located in the left circumflex artery.A 2.75x24mm promus element¿ drug-eluting stent was advanced but failed to cross the lesion.During withdrawal, it was noted that the stent strut was lifted up.The procedure was completed with another of the same device.No 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: 7151160
• MDR Text Key: 96025169
• Report Number: 2134265-2017-12800
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: CN
• 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,Followup
• Report Date: 12/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/11/2017
• Device Model Number: H7493911324270
• Device Catalogue Number: 39113-2427
• Device Lot Number: 19293037
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/11/2017
• Initial Date FDA Received: 12/28/2017
• Supplement Dates Manufacturer Received: 01/11/2018
• Supplement Dates FDA Received: 01/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2016
• 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