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

Model Number 9551

Device Problems Fracture (1260); Defective Device (2588); Difficult to Advance (2920); Device Dislodged or Dislocated (2923); Material Deformation (2976)

Patient Problems Perforation of Vessels (2135); Swelling/ Edema (4577)

Event Date 07/27/2023

Event Type  Injury  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that stent enlargement, stent dislodgement, stent fracture, vessel trauma and limb swelling occurred.The patient underwent a percutaneous coronary intervention of the 80% stenosed target lesion located in the mildly tortuous and non-calcified left anterior descending artery.A 24 x 3.00 promus premier drug-eluting stent was advanced for treatment; however, the stent appeared significantly enlarged during introduction.It was noted the insufficient support of the guide catheter resulted in the stent being unable to reach the lesion.The stent strut partially broke and dislodged in the radial artery.The stent was removed with a snare.After removal, local limb swelling was found, and the radial artery and brachial artery walls were injured multiple times.After replacing the guide catheter, another 24 x 3.00 promus premier drug-eluting stent was used to complete the procedure.There were no further complications reported and the patient was discharged.

Manufacturer Narrative

E1 - initial reporter facility name: (b)(6).E1- initial reporter address 1: (b)(6).E1 - initial reporter phone: (b)(6).

Event Description

It was reported that stent enlargement, stent dislodgement, stent damage, vessel trauma and limb swelling occurred.The patient underwent a percutaneous coronary intervention of the 80% stenosed target lesion located in the mildly tortuous and non-calcified left anterior descending artery.A 24 x 3.00 promus premier drug-eluting stent was advanced for treatment; however, the stent appeared significantly enlarged during introduction.It was noted the insufficient support of the guide catheter resulted in the stent being unable to reach the lesion.The stent strut partially broke and dislodged in the radial artery.The stent was removed with a snare.After removal, local limb swelling was found, and the radial artery and brachial artery walls were injured multiple times.After replacing the guide catheter, another 24 x 3.00 promus premier drug-eluting stent was used to complete the procedure.There were no further complications reported and the patient was discharged.It was further reported that the stent did not break into pieces.

Event Description

It was reported that stent enlargement, stent dislodgement, stent fracture, vessel trauma and limb swelling occurred.The patient underwent a percutaneous coronary intervention of the 80% stenosed target lesion located in the mildly tortuous and non-calcified left anterior descending artery.A 24 x 3.00 promus premier drug-eluting stent was advanced for treatment; however, the stent appeared significantly enlarged during introduction.It was noted the insufficient support of the guide catheter resulted in the stent being unable to reach the lesion.The stent strut partially broke and dislodged in the radial artery.The stent was removed with a snare.After removal, local limb swelling was found, and the radial artery and brachial artery walls were injured multiple times.After replacing the guide catheter, another 24 x 3.00 promus premier drug-eluting stent was used to complete the procedure.There were no further complications reported and the patient was discharged.It was further reported that the stent did not break into pieces.It was further reported that the stent was found deformed and dislodged after exiting the 6f guide catheter.The patient was hospitalized for observation due to the injury to the radial artery and was discharged one week later.

Manufacturer Narrative

E1 - initial reporter facility name: (b)(6).E1- initial reporter address 1: (b)(6).E1 - initial reporter phone: (b)(6).The device was not returned for analysis.However, an analysis was performed on the received photo of the device.Within the photo, the stent appears detached from the delivery system, with observable damage along the entire length of the stent.

• Brand Name: PROMUS PREMIER
• 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: 17589328
• MDR Text Key: 321586406
• Report Number: 2124215-2023-44402
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9551
• Device Catalogue Number: 9551
• Device Lot Number: 0030933707
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2023
• 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 Outcome(s): Required Intervention; Hospitalization