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

Model Number 10662

Device Problem Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/18/2021

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: a 12 x 3.00mm promus premier select stent delivery system was returned for analysis.The device was received in two sections as a result of a break in the extrusion.The stent protector was covering the crimped stent and the product mandrel was fully loaded through the wire lumen.The stent protector was removed with no resistance.A visual and microscopic 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 between the proximal and distal markerbands.The 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 bumper tip identified no damage.A visual and tactile examination of the hypotube found multiple hypotube kinks.The device was received in two sections as a result of a break in the midshaft extrusion.The break was located at 108cm distal to the distal end of strain relief.A microscopic examination of the wire lumen identified no damage.The product mandrel was removed from the wire lumen with no resistance.A verified 0.014 inch guidewire was loaded through the distal end of the tip and wire lumen with no resistance noted.No other issues were identified during the product analysis.

Event Description

On 22sep2021 reportable on an device analysis completed on 22sep2021.A percutaneous coronary intervention (pci) was performed on a patient diagnosed with coronary heart disease.A 12 x 3.00 promus premier select stent was selected for treatment, and while outside the patient, difficulty loading the wire occurred.It was noted that the stent could not be threaded through the wire.There were difficulties advancing the wire through the device.No issues were noted with the device, out of packaging.No patient complications resulted in relation to this event.However, device returned and analysis revealed a shaft break.

• 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: 12591664
• MDR Text Key: 275219856
• Report Number: 2134265-2021-12204
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/25/2022
• Device Model Number: 10662
• Device Catalogue Number: 10662
• Device Lot Number: 0025945102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/22/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/25/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1