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

Model Number H7493911316250

Device Problem Occlusion Within Device (1423)

Patient Problem Reocclusion (1985)

Event Date 11/12/2017

Event Type  Injury  

Manufacturer Narrative

Complainant name: (b)(6) hospital.Device is a combination product.Device evaluated by mfr.: it is indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.(b)(4).

Event Description

It was reported that coronary heart disease and in-stent restenosis occurred.In (b)(6) 2013, the patient presented and the index procedure was performed.The target lesion was located in distal right coronary artery (rca) with 100% stenosis, and was 16mm long with a reference vessel diameter of 2.5mm.The target lesion was treated with pre-dilatation and placement of a 2.50x16mm promus element¿ drug-eluting stent.Following post dilation, residual stenosis was 0%.After twelve days, the patient was discharged on aspirin and clopidogrel.In (b)(6) 2017, the patient was diagnosed with a coronary heart disease and was hospitalized on the same day.On the next day, the 90% in-stent restenosis noted in distal rca was treated with percutaneous coronary intervention (pci) with unknown residual stenosis.After four days, the event was considered to be recovered/resolved with sequelae and the patient was discharged on the same day.

Manufacturer Narrative

(b)(4).

Event Description

This same event was reported under mdr id 2134265-2018-02314.Any further updates will be added mdr id 2134265-2018-02314 only.

• Brand Name: PROMUS ELEMENT ¿
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7343454
• MDR Text Key: 102575442
• Report Number: 2134265-2018-02305
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: CN
• PMA/PMN Number: SIMILAR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/05/2018

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/15/2014
• Device Model Number: H7493911316250
• Device Catalogue Number: 39113-1625
• Device Lot Number: 0015617883
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/05/2018
• Initial Date FDA Received: 03/15/2018
• Supplement Dates Manufacturer Received: 03/30/2018
• Supplement Dates FDA Received: 03/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/06/2012
• 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): Hospitalization; Required Intervention
• Patient Age: 27 YR