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

Model Number H7493911316350

Device Problems Occlusion Within Device (1423); Device Operates Differently Than Expected (2913)

Patient Problems Calcium Deposits/Calcification (1758); Congestive Heart Failure (1783); Death (1802); Reocclusion (1985)

Event Date 07/27/2015

Event Type  Death  

Manufacturer Narrative

Device is a combination product.Device evaluated by mfr.: it is indicated that the device will not be returned for evaluation.A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted.If there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Event Description

Same case as mdr id: 2134265-2015-07725, 2134265-2015-07726.(b)(6) clinical study.It was reported that the patient died.The index procedure was performed on (b)(6) 2012.The 90%stenosed target lesion, 3.5x10mm, de novo, eccentric, type b2 coronary lesion with a =< 45 degree bend and timi 3 flow, and was located in the severely calcified and moderately tortuous mid right coronary (rca) artery.The physician treated the lesion with pre-dilatation and placement of a 3.5x16mm promus element stent at 12 atmospheres.Following post dilatation, residual stenosis was 0% with timi 3 flow.Target lesion # 2 was a 90% stenosed target lesion, 3.0x15mm, de novo, eccentric, type b2 coronary lesion with a =< 45 degree bend and timi 3 flow, and was located in the severely calcified and moderately tortuous mid of distal rca artery.Target lesion #2 was treated with pre-dilatation and placement of a 3.0x28mm promus element stent at 12 atmospheres.Following post dilatation, residual stenosis was 0% with timi 3 flow.Target lesion # 3 was a 90% stenosed target lesion, 3.0x15mm, de novo, eccentric, type b2 coronary lesion with a =< 45 degree bend and timi 3 flow, and was located in the severely calcified and moderately tortuous distal rca artery.Target lesion #3 was treated with pre-dilatation and placement of a 3.0x28mm promus element stent at 12 atmospheres.Following post dilatation, residual stenosis was 0% with timi 3 flow.One post procedure, the patient was discharged on aspirin and clopidogrel.In (b)(6) 2015, the patient developed congestive heart failure.Medication was given and angiography was performed and revealed isr in the previously implanted stent in the mid rca.In (b)(6) 2015, the patient died due to congestive heart failure.

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that in (b)(6) 2015, in-stent restenosis (isr) was noted in the previously implanted 3.50x16mm promus element stent in mid right coronary artery (rca).

• 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: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5235884
• MDR Text Key: 31608474
• Report Number: 2134265-2015-07724
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• 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: 10/23/2015

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 Model Number: H7493911316350
• Device Catalogue Number: 39113-1635
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/23/2015
• Initial Date FDA Received: 11/19/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Death
• Patient Age: 72 YR
• Patient Weight: 74