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

Model Number 9315

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

Patient Problem Complaint, Ill-Defined (2331)

Event Date 12/29/2018

Event Type  Injury  

Manufacturer Narrative

(b)(6).Device is a combination product.

Event Description

It was reported that patient experienced plaque prolapse.Vascular access was obtained via the right femoral artery.The 90% stenosed, 35x3.0mm, concentric target lesion was located in the none tortuous proximal to mid right coronary artery.The lesion contained >45 and <90 degrees bend.Following pre-dilation with a 2.0x09mm non-bsc balloon catheter, residual stenosis was 60%.A 3.00x38mm promus element drug-eluting stent was successfully implanted at nominal pressure.However, post deployment, a plaque prolapse was noted distal to the stent.To cover the distal prolapse plaque, the physician then deployed a 2.5 x 15mm non-bsc stent and the procedure was completed.No patient complications were reported with timi iii flow established and the patient's status was stable.

• Brand Name: PROMUS ELEMENT LONG
• 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 IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 8268870
• MDR Text Key: 133864278
• Report Number: 2134265-2019-00187
• 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: 01/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/22/2019
• Device Model Number: 9315
• Device Catalogue Number: 9315
• Device Lot Number: 0020951770
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2017
• 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: 68 YR
• Patient Weight: 74