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

Model Number 9548

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/22/2019

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.Device is a combination product.

Event Description

It was reported that a shaft break occurred.A 12 x 3.00 promus premier stent was advanced to the target lesion and deployed.While withdrawing the delivery system, the shat broke in a heavily calcified femoralis.The device was removed and the procedure was completed with another of the same device.No patient complications were reported in relation to this event and the patient was reported to be stable following the procedure.

Manufacturer Narrative

Age at time of event: 18 years or older.Device is a combination product.Device evaluated by mfr:a 12 x 3.00 mm promus premier stent delivery system was returned for analysis.A visual examination of the stent found no issues on the stent.There were no signs of damage, stretching or lifting of the stent struts.The stent showed no signs of movement and was set between the proximal and distal markerbands.The crimped stent od (outer diameter) was measured and the result was within the maximum 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 examination of the tip showed signs of damage.Tip damage most likely occurred when the tip was pushed against a restriction.A visual and tactile examination of the hypotube found multiple kinks along several locations of the hypotube shaft and a hypotube break was noted at approximately 19.7 cm distal to the distal end of strain relief.The damages noted on the hypotube most likely occurred due to manipulation of the device during the procedure.A visual and tactile examination of the outer lumen and mid-shaft section and a visual examination of the inner lumen found no issues with the extrusion shaft.No other issues were identified during the product analysis.

Event Description

It was reported that a shaft break occurred.A 12 x 3.00 promus premier stent was advanced to the target lesion and deployed.While withdrawing the delivery system, the shat broke in a heavily calcified femoralis.The device was removed and the procedure was completed with another of the same device.No patient complications were reported in relation to this event and the patient was reported to be stable following the procedure.It was later reported that vascular access was obtained through the femoralis as this was the only artery usable.

• 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: 9654528
• MDR Text Key: 178645722
• Report Number: 2134265-2020-00768
• 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
• Type of Report: Initial,Followup
• Report Date: 02/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/15/2021
• Device Model Number: 9548
• Device Catalogue Number: 9548
• Device Lot Number: 0023689955
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2020
• Date Manufacturer Received: 02/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1