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

Model Number 9551

Device Problem Activation Failure (3270)

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

Event Date 03/02/2022

Event Type  malfunction  

Event Description

It was reported that stent insufficient apposition occurred.The target lesion was located in the severely calcified left anterior descending artery.A 24 x 2.75 promus premier drug-eluting stent was advanced for treatment.However, during procedure, it was noted that the stent did not fully expand and it could not oppose the lesion.The procedure was completed with another of the same device.There were no patient complications and the patient was stable.

Manufacturer Narrative

Device evaluated by mfr: the promus premier ous mr 24 x 2.75mm stent delivery system was returned for analysis.A visual examination of the stent found proximal and mid-stent damage, with stent struts lifted and pulled distally.The undamaged crimped stent outer diameter (od) was measured and the result was within maximum crimped stent profile measurement.The balloon cones were reviewed and damage was identified on the proximal balloon cone, at the site of the proximal stent damage.The balloon wings showed no signs of inflation.A visual and microscopic examination of the bumper tip showed no signs of damage.A visual and tactile examination of the hypotube shaft found multiple hypotube kinks at several locations along 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 with the extrusion shaft.Functional testing revealed that a recommended guidewire loaded via the distal tip without issue.The returned device was attached to an encore inflation device and an attempt was made to inflate the device to rated burst pressure, however pressure could not be maintained over 4atm due to a leak identified at the proximal balloon cone.No other issues were identified during analysis.

Event Description

It was reported that stent insufficient apposition occurred.The target lesion was located in the severely calcified left anterior descending artery.A 24 x 2.75 promus premier drug-eluting stent was advanced for treatment.However, during procedure, it was noted that the stent did not fully expand and it could not oppose the lesion.The procedure was completed with another of the same device.There were no patient complications and the patient 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: 13953661
• MDR Text Key: 288285650
• Report Number: 2134265-2022-03058
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: CH
• 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: 05/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/07/2023
• Device Model Number: 9551
• Device Catalogue Number: 9551
• Device Lot Number: 0027994047
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/07/2021
• 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
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 67 KG