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

Model Number 9550

Device Problem Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/01/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: used the first date of the month of the aware date as no event date was provided.Device is a combination product.

Event Description

Reportable based on device analysis completed on 06-dec-2018.It was reported that advancing difficulties through another device were encountered.A 20x2.25mm promus premier drug-eluting stent was selected for use to treat the lesion.However, it was noted that the stent would not go through the guider.The device was removed and the procedure was completed with another of the same device.No patient complications were reported.However, returned device analysis revealed stent damaged.Promus premier ous mr 20 x 2.25 mm stent delivery system was returned for analysis.A visual examination of the stent found damage to the distal end of the stent with stent struts misaligned.The undamaged crimped stent outer diameter was measured and the result was within maximum crimped stent profile measurement.A visual and microscopic examination of the bumper tip showed 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 hypotube found multiple hypotube kinks.A visual and tactile examination of the shaft polymer extrusion found no issues along the mid shaft, inner or outer shaft polymer extrusion.No other issues were identified during the product analysis.

• 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 IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 8181307
• MDR Text Key: 130991776
• Report Number: 2134265-2018-64447
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/23/2020
• Device Model Number: 9550
• Device Catalogue Number: 9550
• Device Lot Number: 0022183123
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/24/2018
• 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