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

Model Number 9548

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hematoma (1884); Vascular Dissection (3160)

Event Date 06/26/2023

Event Type  Injury  

Event Description

It was reported that the patient experienced dissection and hematoma requiring additional intervention.A 12 x 2.50 promus premier drug-eluting stent (des) was selected for treatment.However, during the procedure, dissection and hematoma appeared at the edge of the blood vessel where the unexpanded stent was placed.The device was withdrawn and the procedure was completed with a wolverine cutting balloon and a new stent was implanted.It was noted that the cause of the event was related to the patient's own issue.No further patient complications were reported.

Manufacturer Narrative

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

Manufacturer Narrative

(b)(6).Device evaluated by mfr: promus premier ous mr 12 x 2.50mm stent delivery system (sds) was returned to the complaint investigation site (cis).Visual, tactile and microscopic analysis was performed on the device.No issues identified with the hypotube shaft.No issues identified with the outer / mid-shaft sections or the inner lumen of the device.There was no sign of damage, stretching or lifting of the stent struts.Balloon cones were reviewed, and no issues were noted.Balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.No signs of movement, stent was set between the proximal and distal markerbands.Bumper tip showed no signs of distal tip damage.

Event Description

It was reported that the patient experienced dissection and hematoma requiring additional intervention.A 12 x 2.50 promus premier drug-eluting stent (des) was selected for treatment.However, during the procedure, dissection and hematoma appeared at the edge of the blood vessel where the unexpanded stent was placed.The device was withdrawn, and the procedure was completed with a wolverine cutting balloon and a new stent was implanted.It was noted that the cause of the event was related to the patient's own issue.No further patient complications were reported.

• 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: 17579884
• MDR Text Key: 321510833
• Report Number: 2124215-2023-40951
• 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: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9548
• Device Catalogue Number: 9548
• Device Lot Number: 0030130857
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 07/27/2023
• Initial Date FDA Received: 08/18/2023
• Supplement Dates Manufacturer Received: 11/02/2023
• Supplement Dates FDA Received: 11/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/05/2022
• 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 Outcome(s): Required Intervention