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

Model Number 10662

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 02/23/2021

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: (b)(6) years or older.

Event Description

It was reported that filaments were visible on a stent.During preparation and while outside the patient, filaments were visible on a 12 x 4.00 promus premier select.It was noted that two small filaments are visible at the distal end of the stent.The stent was not used.The procedure was completed with another of the same device.There was no impact to the patient during the whole procedure and the patient was reported to be stable following the procedure.

Event Description

It was reported that filaments were visible on the stent.During preparation and while outside the patient, filaments were visible on a 12 x 4.00 promus premier select.It was noted that two small filaments are visible at the distal end of the stent.The stent was not used.The procedure was completed with another of the same device.There was no impact to the patient during the whole procedure and the patient was reported to be stable following the procedure.

Manufacturer Narrative

Age at time of event: 18 years or older.Device evaluated by mfr: a 12 x 4.00mm promus premier select stent delivery system was returned for analysis.A visual examination of the crimped stent found a fibre caught in the stent struts at the proximal end of the stent.There was no evidence of any damage to the struts.The crimped stent od (outer diameter) was measured and the result was within maximum crimped stent profile measurement.An attempt to remove the entire fibre resulted in the fibre breaking.The approximate length of both sections of the fibre is 2cm.Inspection on the detached section of fibre, identified that the fibre was consistent with that of a polyester fibre.Polyester fibres are defined as a common synthetic fibre.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 showed no signs of damage.A visual and tactile examination of the hypotube found no issues.A visual examination of the outer and inner lumen and mid shaft section found no issues along the shaft polymer extrusion.No other issues were identified during the product analysis.

• 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
• MDR Report Key: 11474580
• MDR Text Key: 239492549
• Report Number: 2134265-2021-03083
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• 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: 05/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/27/2022
• Device Model Number: 10662
• Device Catalogue Number: 10662
• Device Lot Number: 0026292846
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2021
• Date Manufacturer Received: 04/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1