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

Model Number 9554

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

Patient Problem Vascular Dissection (3160)

Event Date 03/09/2024

Event Type  Injury  

Event Description

It was reported that a dissection occurred.The 80% stenosed target lesion was located in the moderately tortuous and moderately calcified proximal-mid right coronary artery (rca).Following pre dilation of lesion with a 2.50 x 12 mm non-compliant balloon, a 3.00 x 38 mm promus premier stent was deployed at 16 atm for 10 sec.A 3.00 x 12 mm non-compliant balloon was used to post dilate the stent and a distal edge type b dissection was noted.The patient experienced slow flow.The dissection was covered with another 2.75 x 12 mm promus premier stent, and the procedure was completed successfully.The patient fully recovered and was stable post procedure.

Manufacturer Narrative

Attached to the complaint record was cine media.Media review by a bsc medical safety director observed an edge dissection during percutaneous coronary intervention (pci) with successful treatment with another stent.

Event Description

It was reported that a dissection occurred.The 80% stenosed target lesion was located in the moderately tortuous and moderately calcified proximal-mid right coronary artery (rca).Following pre dilation of lesion with a 2.50 x 12 mm non-compliant balloon, a 3.00 x 38 mm promus premier stent was deployed at 16 atm for 10 sec.A 3.00 x 12 mm non-compliant balloon was used to post dilate the stent and a distal edge type b dissection was noted.The patient experienced slow flow.The dissection was covered with another 2.75 x 12 mm promus premier stent, and the procedure was completed successfully.The patient fully recovered and was stable post procedure.

• 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: 18954534
• MDR Text Key: 338304724
• Report Number: 2124215-2024-17273
• 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,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9554
• Device Catalogue Number: 9554
• Device Lot Number: 0032553013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Race: Asian