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

Model Number 10667

Device Problems Failure to Advance (2524); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/16/2020

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.

Event Description

It was reported that failure to cross a lesion and stent damage occurred.A percutaneous transluminal coronary angioplasty was performed on a lesion.A 32 x 3.00 promus premier select stent was advanced to the target lesion, but was unable to cross the lesion.When the stent was removed, damage to the stent struts was noticed.The procedure was completed with another of the same device.No patient complications resulted 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 evaluated by mfr: a 32 x 3.00mm promus premier select stent delivery system was returned for analysis.An examination (visual and via scope) of the crimped stent found stent damage.Stent struts from the proximal region of the stent was noted to be lifted and pulled.The undamaged 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 showed no signs of damage.A visual and tactile examination of the hypotube found multiple kinks along the length of the hypotube shaft.A visual and tactile examination of the outer and mid shaft section and a visual examination of the inner lumen found no issues along the shaft polymer extrusion.No other issues were identified during the product analysis.

Event Description

It was reported that failure to cross a lesion and stent damage occurred.A percutaneous transluminal coronary angioplasty was performed on a lesion.A 32 x 3.00 promus premier select stent was advanced to the target lesion, but was unable to cross the lesion.When the stent was removed, damage to the stent struts was noticed.The procedure was completed with another of the same device.No patient complications resulted in relation to this event and the patient was reported to be stable following the procedure.

• 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: 11056949
• MDR Text Key: 223182572
• Report Number: 2134265-2020-18282
• 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: 02/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/08/2022
• Device Model Number: 10667
• Device Catalogue Number: 10667
• Device Lot Number: 0026182322
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2021
• Initial Date Manufacturer Received: 12/16/2020
• Initial Date FDA Received: 12/22/2020
• Supplement Dates Manufacturer Received: 02/02/2021
• Supplement Dates FDA Received: 02/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1