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

Model Number 9552

Device Problems Device Markings/Labelling Problem (2911); Device Dislodged or Dislocated (2923); Material Deformation (2976)

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

Event Date 01/02/2023

Event Type  malfunction  

Manufacturer Narrative

Initial reporter address: (b)(6).

Event Description

It was reported that stent moved on balloon and labelling issue occurred.The 90% stenosed target lesion was located in the mildly tortuous and mildly calcified left anterior descending artery.A 28 x 4.00 promus premier drug-eluting stent was selected for use.However, before it entered the patient's body, it was noticed that the stent was deformed and was moved on balloon.Furthermore, the batch number of the inner packaging was different from that of the outer packaging.The procedure was completed with another of the same device.There were no complications reported and the patient is stable.

Manufacturer Narrative

E1: initial reporter address 1: (b)(6).Device evaluation by mfr: the promus premier 28/4.00mm stent delivery system was returned for analysis.Stent outer diameter could not be measured due to damage.Distal end of stent dislodged from balloon and pulled distally over the tip.The balloon cones were reviewed, and the were in a wrapped states, with no signs of positive pressure applied.A visual and microscopic examination of the bumper tip showed no signs of distal tip damage.A visual and tactile examination of the hypotube shaft found multiple kinks.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 analysis.

Event Description

It was reported that stent moved on balloon and labelling issue occurred.The 90% stenosed target lesion was located in the mildly tortuous and mildly calcified left anterior descending artery.A 28 x 4.00 promus premier drug-eluting stent was selected for use.However, before it entered the patient's body, it was noticed that the stent was deformed and was moved on balloon.Furthermore, the batch number of the inner packaging was different from that of the outer packaging.The procedure was completed with another of the same device.There were no complications reported and the patient is 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16311163
• MDR Text Key: 308967877
• Report Number: 2124215-2023-04895
• 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: 03/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9552
• Device Catalogue Number: 9552
• Device Lot Number: 0030065598
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/22/2022
• 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: 63 YR
• Patient Sex: Male
• Patient Weight: 75 KG