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

Model Number H7493911428270

Device Problem Occlusion Within Device (1423)

Patient Problems Atherosclerosis (1728); Dyspnea (1816); Fatigue (1849); Ischemia (1942); Reocclusion (1985)

Event Date 09/01/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device is a combination product.Device evaluated by mfr: the complaint device was not returned for analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The root cause is anticipated procedural complications as this event is a known physiological effect of the procedure and is noted within the dfu.(b)(4).

Event Description

Same case as mdr id: 2134265-2015-07327 and 2134265-2015-07328.Promus element plus clinical study it was reported that stent restenosis occurred.In (b)(6) 2012, the patient presented due to unstable angina and was referred for cardiac catheterization.Subsequently, coronary angiography and index procedure were performed.Target lesion # 1 was a de novo lesion located in the 1st diagonal with 90% stenosis and was 28mm long with a reference vessel diameter of 3.50mm.Target lesion # 1 was treated with direct stent placement using a 2.50mmx12mm promus element plus stent.Following post dilatation, residual stenosis was 0%.Target lesion # 2 was a de novo lesion located in the proximal right coronary artery (rca) with 80% stenosis and extending to distal rca with 90% stenosis and was 2.50mm long with a reference vessel diameter of 2.50mm.The 90% distal stenosis in rca was treated with pre-dilatation and placement of 2.75x28mm.The 80% proximal stenosis in rca was treated with placement of 3.50x28mm and 4.00x12.0mm promus element plus stents with 0% residual stenosis.The following day, the patient was discharged on aspirin and clopidogrel.In (b)(6) 2015, the patient presented with dyspnea and abnormal stress test and was diagnosed with coronary atherosclerosis and was hospitalized on the same day.Subsequently, the patient was referred for cardiac catheterization.The 99% stenosis located in distal rca was treated with balloon angioplasty and placement of a 3.00x32.00 mm promus premier drug eluting stent with no residual stenosis.The following day, the event was considered recovered and the patient was discharged on aspirin and clopidogrel.

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that during index procedure, target lesion #2 was 80% stenosed and not 90% as previously reported.In (b)(6) 2015, the patient presented for follow up visit after recent stress test which shown the evidence of silent ischemia.Patient also had symptoms of fatigue and shortness of breath.After the placement of 3.00x32.00 mm promus premier drug eluting stent to treat the stenosis located in the mid extending to distal right coronary artery (rca), post-dilatation was performed resulting to 0% residual stenosis.

• Brand Name: PROMUS ELEMENT¿ PLUS
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5198514
• MDR Text Key: 30288528
• Report Number: 2134265-2015-07326
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/21/2012
• Device Model Number: H7493911428270
• Device Catalogue Number: 39114-2827
• Device Lot Number: 14995121
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/17/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2012
• 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: 69 YR