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

Model Number 10664

Device Problem Defective Device (2588)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/10/2020

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: a 20 x 2.50mm promus premier select stent delivery system (sds) was returned for analysis.A visual examination of the stent found that the stent was damaged on proximal stent strut rows, stent struts were lifted.The undamaged section crimped stent od (outer diameter) was measured and the result was within 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 and microscopic 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 no issues with the hypotube shaft.A visual and tactile examination of the outer and mid shaft section and a visual examination of the inner extrusion found no issues along the shaft polymer extrusion.No other issues were identified during the product analysis.

Event Description

It was reported that stent device was faulty.During a percutaneous coronary intervention (pci), a 20 x 2.50 promus premier select was noted to have had fault in the material.The procedure was completed with another of the same device.No patient complications were reported in relation to this event.However, device returned and analysis revealed stent damage.

• Brand Name: PROMUS PREMIER SELECT
• 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: 10032740
• MDR Text Key: 190677148
• Report Number: 2134265-2020-06134
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 05/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/02/2021
• Device Model Number: 10664
• Device Catalogue Number: 10664
• Device Lot Number: 0024397563
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/14/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/03/2019
• 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