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

Model Number 9548

Device Problem Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/02/2020

Event Type  malfunction  

Manufacturer Narrative

Initial reporter facility name: (b)(6).Device evaluated by mfr.: promus premier ous mr 12 x 2.75 mm stent delivery system was returned for analysis.An examination (visual and via scope) of the crimped stent found stent damage.Stent struts from the mid and distal stent region were noted to be lifted from their crimped position and pulled proximally and distally.The undamaged crimped stent outer diameter was measured and the result was within max crimped stent profile measurement.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 microscopic examination of the bumper tip showed no signs of tip damage.A visual and tactile examination of the hypotube shaft found multiple kinks located at different places along the length of the hypotube shaft.A visual and tactile examination of the outer and mid-shaft section and a visual examination of the inner lumen found no issues along the shaft polymer extrusion.The device was loaded without issues on a 0.014 inch test guidewire.No other issues were identified during the product analysis.

Event Description

Reportable based on device analysis completed on 02sep2020.It was reported that advancing difficulties were encountered.The chronically occluded diffused target lesion was located in the left anterior descending artery.After a guide wire was advanced to the distal end of the lesion, pre-dilatation was performed with a 1.2x12mm balloon catheter.There was a branch bifurcation lesion in the middle segment.A 12 x 2.75 promus premier drug-eluting stent was advanced but could not reach the lesion and the stent was stuck.The physician retrieved the stent through the catheter.The procedure was completed with another of the same device.There were no patient complications reported and the patient's status was stable.However, returned device analysis revealed a stent damage.

• Brand Name: PROMUS PREMIER
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 10594024
• MDR Text Key: 208796311
• Report Number: 2134265-2020-12408
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 09/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/13/2020
• Device Model Number: 9548
• Device Catalogue Number: 9548
• Device Lot Number: 0022405861
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/02/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2018
• 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
• Patient Age: 54 YR
• Patient Weight: 67