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

Model Number UNK758

Device Problems Bent (1059); Occlusion Within Device (1423); Device Damaged by Another Device (2915)

Patient Problem Reocclusion (1985)

Event Date 01/25/2018

Event Type  Injury  

Manufacturer Narrative

Age at time of event: 18 years or older.Device is a combination product.If implanted, give date: 2014.(b)(4).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

Same case as mdr id: 2134265-2018-01021.It was reported that in-stent restenosis and stent damage occurred.In 2014, a promus premier¿ drug-eluting stent was implanted in the left circumflex artery (lcx).In (b)(6) 2018, the patient was presented with 99% in-stent restenosis (isr), with moderate tortuosity and severe calcification in the previously implanted promus premier¿ stent in lcx.Percutaneous coronary intervention was then performed.Pre-dilation was performed, however the isr was not expanded sufficiently.Residual stenosis was still 99%.Intravascular ultrasound (ivus) was then performed with opticross¿ imaging catheter.Imaging pullback was performed normally.However, during removal when the physician attempted to pull the ivus catheter, resistance was encountered.The catheter became stuck with the previously implanted promus premier¿ stent.The physician pulled the ivus catheter with force and device got detached at the guidewire port at 1.5 centimeters from the tip.The physician attempted to retrieve the detached tip with a goose neck snaring device but was unsuccessful.The detached tip was then crimped to the lcx vessel wall with a 3.5 x 28 mm synergy stent.Subsequently, it was noticed that the promus premier¿ stent had shortened.The stent was then expanded and the procedure was completed.The device fragment left inside the patient's body is under follow up observation.No further patient complications were reported.

• Brand Name: PROMUS PREMIER¿
• 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: 7286224
• MDR Text Key: 100581207
• Report Number: 2134265-2018-01022
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• PMA/PMN Number: P110010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/25/2018

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?: Yes
• Device Operator: Health Professional
• Device Model Number: UNK758
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/25/2018
• Initial Date FDA Received: 02/21/2018
• 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
• Treatment: BALLOON CATHETER: SAPPHIRE 1.0, TAZUNA2.0, NSE3.5; GUIDE CATHETER: HYPERION AL1.5; GUIDEWIRE: SION BLUE; IMAGING CATHETER: OPTICROS
• Patient Outcome(s): Required Intervention