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

Model Number 10664

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

Patient Problems Ischemia (1942); Vascular Dissection (3160)

Event Date 12/28/2021

Event Type  Injury  

Event Description

It was reported that a dissection occurred.The target lesion was located in a 100% occluded moderately tortuous right coronary artery (rca).Following predilatation, a 24 x 4.00 promus premier select was deployed in the rca.Following deployment, stent strut damage was noted from the mid to distal edge of the drug eluting stent.Another 24 x 4.00 promus premier select was deployed to cover the previously placed damaged stent.Following the second stent deployment, a distal edge dissection was noted.A 3.00 x 20 promus premier select was deployed to cover the dissection and complete the procedure.No further patient complications resulted in relation to this event.

Manufacturer Narrative

A3 sex and d6a implant date: corrected.

Event Description

It was reported that a dissection occurred.The target lesion was located in a 100% occluded moderately tortuous right coronary artery (rca).Following predilatation, a 24 x 4.00 promus premier select was deployed in the rca.Following deployment, stent strut damage was noted from the mid to distal edge of the drug eluting stent.Another 20 x 4.00 promus premier select was deployed to cover the previously placed damaged stent.Following the second stent deployment, a distal edge dissection was noted.A 3.00 x 20 promus premier select was deployed to cover the dissection and complete the procedure.No further patient complications resulted in relation to this event.

Event Description

It was reported that a dissection occurred.The target lesion was located in a 100% occluded moderately tortuous right coronary artery (rca).Following predilatation, a 24 x 4.00 promus premier select was deployed in the rca.Following deployment, stent strut damage was noted from the mid to distal edge of the drug eluting stent.Another 20 x 4.00 promus premier select was deployed to cover the previously placed damaged stent.Following the second stent deployment, a distal edge dissection was noted.A 3.00 x 20 promus premier select was deployed to cover the dissection and complete the procedure.No further patient complications resulted in relation to this event.It was further reported that a 2mm and a 2.5mm semi compliant (sc) balloons were advanced to predilate the lesion at 10 to 14 atmospheres for 15 seconds.It was noted that the distal to mid stent appeared to be constricted under fluoroscopy.No resistance was encountered while advancing the stent device in the guide catheter or over the wire before deployment of the stent.Post dilatation was not performed.The dissection was noted to be flow limiting.

• Brand Name: PROMUS PREMIER SELECT
• 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: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13237944
• MDR Text Key: 283753904
• Report Number: 2134265-2021-16685
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/10/2022
• Device Model Number: 10664
• Device Catalogue Number: 10664
• Device Lot Number: 0025612431
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female