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

Model Number 9553

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

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

Event Date 12/02/2021

Event Type  malfunction  

Event Description

It was reported that stent damage occurred.The target lesion was located in the left anterior descending artery.A 32 x 2.25 promus premier drug-eluting stent was advanced but failed to cross the lesion.When the physician withdrew the stent outside the patient, it was noted that the stent strut was lifted up.The procedure was completed with a different device.There were no patient complications nor injuries reported and the patient status was stable.

Event Description

It was reported that stent damage occurred.The target lesion was located in the left anterior descending artery.A 32 x 2.25 promus premier drug-eluting stent was advanced but failed to cross the lesion.When the physician withdrew the stent outside the patient, it was noted that the stent strut was lifted up.The procedure was completed with a different device.There were no patient complications nor injuries reported and the patient status was stable.It was further reported that the target lesion was 75% stenosed, severely calcified, and not tortuous.

Manufacturer Narrative

A promus premier ous mr 32 x 2.25mm stent delivery system was returned for analysis.A visual examination of the crimped stent identified that stent struts at the proximal edge of the stent were lifted.The stent was securely crimped between both markerbands.The stent od (outer diameter) was measured within max 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 tip damage.A visual and tactile examination of the hypotube shaft found no damage.Visual, microscopic and tactile examinations of the distal extrusion identified no damage.No other issues were identified during analysis.

Event Description

It was reported that stent damage occurred.The target lesion was located in the left anterior descending artery.A 32 x 2.25 promus premier drug-eluting stent was advanced but failed to cross the lesion.When the physician withdrew the stent outside the patient, it was noted that the stent strut was lifted up.The procedure was completed with a different device.There were no patient complications nor injuries reported and the patient status was stable.It was further reported that the target lesion was 75% stenosed, severely calcified, and not tortuous.

• 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 johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13026949
• MDR Text Key: 282498178
• Report Number: 2134265-2021-15990
• 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,Followup
• Report Date: 02/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/06/2022
• Device Model Number: 9553
• Device Catalogue Number: 9553
• Device Lot Number: 0025713004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/06/2020
• 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: 76 YR
• Patient Sex: Female
• Patient Weight: 58 KG