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

Model Number 9547

Device Problems Break (1069); Fracture (1260)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 01/08/2019

Event Type  malfunction  

Manufacturer Narrative

Device is a combination product.

Event Description

It was reported that shaft break occurred.A 8 x 3.00 promus premier stent was selected for use.However, it was noted that the stent wire broke in half.No known patient complications were reported.

Manufacturer Narrative

Device is a combination product.Device evaluated by mfr.: promus premier ous mr 8 x 3.00 mm stent delivery system was returned for analysis.A visual examination of the stent found no issues.There was no sign of damage, stretching or lifting of the stent struts.The stent showed no signs of movement and was set equidistant between the proximal and distal markerbands.The crimped stent od (outer diameter) was measured and the result was within maximum crimped stent profile measurement.A visual and microscopic examination of the bumper tip found 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 a hypotube break 245 mm distal from the distal end of the strain relief.Multiple hypotube kinks were also noted.A visual and tactile examination of the shaft polymer extrusion found no issues.No other issues were identified during the product analysis.

Event Description

It was reported that shaft break occurred.A 8 x 3.00 promus premier stent was selected for use.However, it was noted that the stent wire broke in half.No known patient complications were reported.It was further reported that the device was removed together with the wire and the procedure was completed with another stent.

• Brand Name: PROMUS PREMIER
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8320048
• MDR Text Key: 135520541
• Report Number: 2134265-2019-00805
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/06/2020
• Device Model Number: 9547
• Device Catalogue Number: 9547
• Device Lot Number: 22526623
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2019
• Date Manufacturer Received: 02/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1