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

Model Number 10667

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

Patient Problem Obstruction/Occlusion (2422)

Event Date 06/29/2020

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.

Event Description

It was reported that significant resistance occurred while operating the devices and additional intervention was performed.The patient was diagnosed with deep venous disease (dvd) in the left anterior descending artery (lad) and right coronary artery (rca) and was referred for a double vessel plasty of the lad and rca.Vascular access was obtained via the femoral artery.The 80% stenosed, 2.50x16mm, de novo target lesion was located in the mildly tortuous ramus artery.A 12mm x 3.50 promus premier select was advanced and successfully deployed in the rca.It was then decided that a plasty of the lad would be performed.After crossing a run through wire, predilitation was performed with a non bsc balloon device.A 32 x 3.50mm promus premier select was advanced and deployed at high pressure in the lad due to diffused disease.Soon after deployment of the stent at high pressure in the lad, it was noticed that the ramus became pinched due to a plaque shift and there was no flow in the ramus.It was noted that significant resistance occurred while operating, and the event was likely due to deployment of a stent at high pressure in the lad.A 16 x 2.50 promus premier select stent was advanced immediately to bail out the stenting in the ramus.No further patient complications were reported and the patient was stable, responding well to medication.

• 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: 10332522
• MDR Text Key: 200614687
• Report Number: 2134265-2020-09908
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: 10667
• Device Catalogue Number: 10667
• Device Lot Number: 0024619367
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/30/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2019
• 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
• Patient Age: 70 YR