MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE TAXUS® LIBERTÉ®; CORONARY DRUG-ELUTING STENT

Model Number H7493893620300

Device Problem Occlusion Within Device (1423)

Patient Problems Chest Pain (1776); Reocclusion (1985); Pain (1994); Tingling (2171); Numbness (2415)

Event Date 04/21/2014

Event Type  Injury  

Event Description

(b)(4).It was reported that in-stent restenosis (isr) occurred.In (b)(6) 2010, the patient was diagnosed with unstable angina and cardiac catheterization was recommended.The index procedure was performed.Target lesion #1 was located in the distal left descending artery (lad) with 70% stenosis and was 13 mm long with a reference vessel diameter of 2.7 mm.The lesion was treated with pre-dilatation and placement of a 2.75 x 16 mm taxus liberte stent, with 0% residual stenosis.Target lesion #2 was located in the mid lad extending upto second diagonal with 85% stenosis and was 18 mm long with a reference vessel diameter of 3.0 mm.The lesion was treated with pre-dilatation and placement of a 3.00 x 20 mm taxus liberte stent, with 0% residual stenosis.Target lesion #3 was located in the proximal lad with 70% stenosis and was 4.0 mm long with a reference vessel diameter of 3.0 mm.The lesion was treated with direct placement of a 3.00 x 8 mm taxus liberte stent, with 0% residual stenosis.One day post procedure, the patient was discharged on aspirin and prasugrel.In (b)(6) 2014, the patient presented with worsening coronary artery disease and was referred for cardiac catheterization.At the time of event, the patient was on aspirin and clopidogrel.The study drug per protocol was last taken on (b)(6) 2013.Target vessel revascularization was performed.The isr in mid lad was treated with balloon angioplasty and placement of 3 x 38 mm non-bsc drug eluting stent, with 0% residual stenosis.A de-novo lesion of distal lad was treated with balloon angioplasty and placement of 3 x 15 mm non-bsc drug eluting stent, with 0% residual stenosis.The event was considered resolved without residual effects.

Manufacturer Narrative

Device is a combination product.Device evaluated by mfr.: it is indicated that the device will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.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).

Manufacturer Narrative

Event date corrected from (b)(6) 2014.(b)(4).

Event Description

Same case as mdr id: 2134265-2014-04147.It was further reported that in (b)(6) 2010, the patient presented with chest pain and cardiac catheterization was recommended.In (b)(6) 2010, the patient presented for repeat cardiac catheterization complaining of continued chest and left shoulder pain and was diagnosed with unstable angina.The three target lesions were a de novo lesion.In (b)(6) 2014, the patient presented to an office visit with complaints of chest pain, numbness and tingling down both arms, and 'gnawing pain' in center of back.Lexican stress test and ct scan of the chest were negative.Eight days from onset of symptoms, the patient returned for scheduled out-patient cardiac catheterization.The patient was recommended to use aspirin and clopidogrel.

• Brand Name: TAXUS® LIBERTÉ®
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: ingrid matte ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 3836757
• MDR Text Key: 4620203
• Report Number: 2134265-2014-02875
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P060008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/30/2014

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: 05/04/2011
• Device Model Number: H7493893620300
• Device Catalogue Number: 38936-2030
• Device Lot Number: 13145095
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/19/2014
• Initial Date FDA Received: 05/28/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/17/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/18/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR