MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM; CORONARY DRUG-ELUTING STENT

Model Number UNK433

Device Problem Occlusion Within Device (1423)

Patient Problems Bradycardia (1751); Myocardial Infarction (1969); Reocclusion (1985); Thrombosis (2100); Chest Tightness/Pressure (2463)

Event Date 05/15/2017

Event Type  Injury  

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: 2134265-2017-07627.(b)(6).It was reported that in-stent restenosis, myocardial infarction, and stent thrombosis occurred.In (b)(6) 2011, a 3.5 x 16mm taxus drug-eluting stent was implanted in proximal right coronary artery (rca).In (b)(6) 2017, clinical status assessment indicated the patient's qualifying condition as stable angina and the patient was further referred for cardiac catheterization.Subsequently, the index procedure and coronary angiography were performed.The de novo target lesion was located in the proximal rca with 90% stenosis and was 20.0mm long with a reference vessel diameter of 3.50mm.The target lesion was treated with pre-dilation and placement of 3.50 x 24mm study stent with 25% residual stenosis.In-stent restenosis (isr) was noted in the 3.5 x 16mm taxus stent, that was previously deployed in proximal rca.Isr of taxus stent was successfully treated with pre-dilation and placement of a 3.50 x 24mm study stent.It was placed in a way to overlap from the mid portion of the taxus stent.An extra-dilation was performed at the proximal stenotic site with drug coated balloon.On the next day, the patient was discharged on dual antiplatelet therapy.In (b)(6) 2017, the patient presented with chest tightness and was hospitalized on the same day.The patient was diagnosed with myocardial infarction (mi) and subsequently was referred for cardiac catheterization.Percutaneous coronary intervention (pci) was recommended and thrombus aspiration was performed in the ostium which led to decrease in stent thrombosis and timi improved to 2.Massive thrombus was observed from ostial to distal for which another aspiration was performed.Aspiration caused a shift to bradycardia which was treated with external pacemaker placement and intra-aortic balloon pump (iabp) insertion with administrating atropine.Timi improved to 3.Subsequent intravascular ultrasound (ivus) revealed huge calcified plaque on the lining in the stent where the lesion was observed.At this stent additional dilatation was performed.Subsequently, total occlusion in proximal rca was treated with pre-dilation and placement of 3.5 x 26mm non-bsc stent.Additionally thrombus aspiration and iabp was performed.Following placement of drug-eluting stent, the residual stenosis was noted to be 0%.Twelve days after, event was considered to be resolved and the patient was discharged on the same day.

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that in (b)(6) 2017, plain old balloon angioplasty (poba) was performed in the stent distal portion for the restenosis in the taxus liberte stent and not for the de novo lesion and a 3.50 x 25mm study stent was deployed at the proximal right coronary artery (rca).On the following day, the patient was discharged on aspirin and clopidogrel.

Manufacturer Narrative

Implant date corrected from (b)(6) 2017 to (b)(6) 2017.(b)(4).

Event Description

It was further reported that on (b)(6) 2017, nicorandil was initiated.On the following day, the intra-aortic balloon pump was removed and the patient's condition requiring noradrenaline to maintain blood pressure continued.Three days after, the administration of noradrenaline was discontinued.Eight days later, the patient was discharged on dual antiplatelet therapy.

• Brand Name: TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM
• Type of Device: CORONARY DRUG-ELUTING STENT
• 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: 6768893
• MDR Text Key: 81900167
• Report Number: 2134265-2017-08156
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• PMA/PMN Number: P060008
• 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,Followup
• Report Date: 07/26/2017

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: UNK433
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/26/2017
• Initial Date FDA Received: 08/04/2017
• Supplement Dates Manufacturer Received: 08/17/2017; 04/02/2018
• Supplement Dates FDA Received: 09/05/2017; 04/25/2018
• 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): Hospitalization; Required Intervention
• Patient Age: 72 YR