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

Model Number 9554

Device Problems Failure to Advance (2524); Material Deformation (2976)

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

Event Date 09/23/2020

Event Type  malfunction  

Event Description

It was reported that the procedure was cancelled.Vascular access was obtained via the radial artery.The 85% stenosed, 36x3.0mm, eccentric, de novo target lesion with a bend of >45 and <90 degrees was located in the severely tortuous and severely calcified left anterior descending artery.After a non-boston scientific guide catheter and a non-boston scientific guidewire were crossed and pre-dilated the lesion with 2x15 and 2.5x15 balloon catheters, a 38 x 3.00 promus premier drug-eluting stent (des) was advanced but failed to cross the lesion and the shaft was kinked.Another 38 x 3.00 promus premier des was advanced but it also failed to cross the lesion and was kinked.The physician decided not to proceed and aborted the procedure.No patient complications reported and the patient's status was stable.

Manufacturer Narrative

Device evaluated by mfr.: promus premier ous mr 38 x 3.00 mm stent delivery system was returned for analysis.A visual 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 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 shaft found a kink along the length of the hypotube shaft measured at 34.8 cm from the distal end of the strain relief.A visual and tactile examination of the outer and mid-shaft section and a visual examination of the inner lumen found no issues.No other issues with device.

Event Description

It was reported that the procedure was cancelled.Vascular access was obtained via the radial artery.The 85% stenosed, 36x3.0mm, eccentric, de novo target lesion with a bend of >45 and <90 degrees was located in the severely tortuous and severely calcified left anterior descending artery.After a non-boston scientific guide catheter and a non-boston scientific guidewire were crossed and pre-dilated the lesion with 2x15 and 2.5x15 balloon catheters, a 38 x 3.00 promus premier drug-eluting stent (des) was advanced but failed to cross the lesion and the shaft was kinked.Another 38 x 3.00 promus premier des was advanced but it also failed to cross the lesion and was kinked.The physician decided not to proceed and aborted the procedure.No patient complications reported and the patient's status was stable.

• 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 CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 10678926
• MDR Text Key: 211332083
• Report Number: 2134265-2020-14195
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: TS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/26/2020
• Device Model Number: 9554
• Device Catalogue Number: 9554
• Device Lot Number: 0022752536
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/27/2018
• 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
• Treatment: GUIDE CATHETER USED (JL 3.5+EBU 3.5); GUIDE CATHETER USED (JL 3.5+EBU 3.5); GUIDEWIRE USED (BMW WHISPER ES); GUIDEWIRE USED (BMW WHISPER ES); GUIDE CATHETER USED (JL 3.5+EBU 3.5); GUIDEWIRE USED (BMW WHISPER ES)
• Patient Age: 84 YR
• Patient Sex: Male
• Patient Weight: 95 KG