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

Model Number H7493911328220

Device Problems Bent (1059); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/15/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that catheter removal difficulties were encountered and stent damage occurred.The target lesion was located in the left circumflex artery.After a non-bsc guide catheter was advanced in the lesion, a 2.25x28mm promus element ¿ drug-eluting stent was advanced but failed to cross the lesion.Upon withdrawal, it became stuck at the tip of the guide catheter and it was noted that the stent struts were lifted.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.: stent delivery system was returned for analysis.A visual examination of the stent found that the stent struts from the proximal end of stent to the mid-section of stent were pushed, moved in a distal direction away from proximal markerband and bunched around the mid-section of the stent.Stent struts were overlapping and misaligned.There was no visible damage on the distal section of the stent.The undamaged section of the crimped stent outer diameter was measured and was within maximum crimped stent profile measurement.Stent damage most likely occurred due to interaction with the guide catheter during withdrawal attempts.The tip was visually and microscopically examined and signs of damage were noted at the distal edge of the tip.This type of damage most likely occurred when the tip was pushed against a restriction.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.Crimp stent markings were visible on the exposed proximal section of the balloon body.A visual and tactile examination of the device found no kinks or damage along the hypotube shaft.A visual and tactile examination of the inner and outer lumen and mid-shaft section found no issues with the extrusion shaft.The bi-component bond showed no signs of damage or strain.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 investigation conclusion is caused by other device as another device/drug/subsequent procedure caused the complaint event.(b)(4).

Event Description

It was reported that catheter removal difficulties were encountered and stent damage occurred.The target lesion was located in the left circumflex artery.After a non-bsc guide catheter was advanced in the lesion, a 2.25x28mm promus element drug-eluting stent was advanced but failed to cross the lesion.Upon withdrawal, it became stuck at the tip of the guide catheter and it was noted that the stent struts were lifted.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: 7635824
• MDR Text Key: 112299901
• Report Number: 2134265-2018-05565
• 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: 05/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/07/2019
• Device Model Number: H7493911328220
• Device Catalogue Number: 39113-2822
• Device Lot Number: 21610100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/08/2018
• 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