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

Model Number 10664

Device Problem Entrapment of Device (1212)

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

Event Date 01/09/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that device entrapment occurred.A percutaneous transluminal coronary angioplasty was being performed.The 90% stenosed target lesion was located in the mildly tortuous and moderately calcified left anterior descending (lad) artery.A 20 x 2.75 promus premier select drug-eluting stent was advanced over a non-boston scientific guidewire.However, during the procedure, the stent got stuck on the guidewire.It was noted that the guidewire was able to be removed from the device outside the patient's body.There were no patient complications reported.

Manufacturer Narrative

E1.Initial reporter address 1: (b)(6).Device evaluated by mfr.: promus select 20 x 2.75mm stent delivery system was returned for analysis.Visual, tactile, microscopic, dimensional testing and device to device interaction testing was performed on the device the device was received with the stent protector placed over the crimped stent and the product mandrel was inserted through the tip and wire lumen.The device was loaded and tracked over a 0.014'' guidewire without issue.The stent protector and mandrel were removed from the device.A microscopic examination of the crimped stent, via scope, found no evidence of stent damage.No signs of movement, stent was set between the proximal and distal markerbands.The crimped stent outer diameter was measured using snap gauge and the result was within maximum crimped stent profile measurement.No issues were identified along the hypotube shaft.The outer and mid-shaft section of the inner lumen found no issues along the shaft polymer extrusion.Balloon cones were reviewed, and no issues were noted.Balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.Bumper tip showed no signs of distal tip damage.

Event Description

It was reported that device entrapment occurred.A percutaneous transluminal coronary angioplasty was being performed.The 90% stenosed target lesion was located in the mildly tortuous and moderately calcified left anterior descending (lad) artery.A 20 x 2.75 promus premier select drug-eluting stent was advanced over a non-boston scientific guidewire.However, during the procedure, the stent got stuck on the guidewire.It was noted that the guidewire was able to be removed from the device outside the patient's body.There were no patient complications reported.

• Brand Name: PROMUS PREMIER SELECT
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 13423809
• MDR Text Key: 285056753
• Report Number: 2134265-2022-00924
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/22/2023
• Device Model Number: 10664
• Device Catalogue Number: 10664
• Device Lot Number: 0027618513
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/22/2021
• 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: 71 YR
• Patient Sex: Female
• Patient Race: Asian