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

Model Number UNK758

Device Problems Malposition of Device (2616); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/06/2015

Event Type  Injury  

Event Description

Same case as mdr id 2134265-2015-01131.It was reported that the stent was not well apposed and foreign material was present.The target lesion was located in the calcified right coronary artery (rca) in long d2.A 20mm x 4.00mm nc quantum apex¿ balloon catheter was advanced to predilate the target lesion.The balloon was initially inflated in the distal of d2 to 16 atmospheres without incident.Upon a second inflation in concentric calcification at 20 atmospheres, the balloon ruptured and tore completely.Upon withdrawal of the device, the proximal part of the balloon was recovered.However, both markers and the distal part of the balloon were missing and remained inside the coronary artery leading to an occlusion of the rca by "inverted parachute effect".It was attempted to pass a guide around the balloon in order to position it downstream; however, this was unsuccessful so an attempt was made to perforate the balloon fragment with a 1.2mm balloon.Once the balloon fragment was punctured, flow was restored to the vessel.After several pre dilations, it was decided to crush the balloon fragment against the vessel wall.It was noted that it was not possible to release the calcified plaque in the proximal portion of the lesion despite several dilation attempts with multiple 3mm non-compliant balloons as the balloons were ruptured by the calcification, even after inflation of a 3.5 mm x 10 mm cutting balloon at 12 atmospheres.The vessel remained visually stable at 50% and a 4.0x24mm promus premier stent was then deployed in the lesion at 16atms.An optical coherence tomography (oct) checkup was performed and it showed a ¿partial wrong affixing¿ of the stent.It was noted that there were difficulties with stent apposition, some aspects of pre-stenting dissection and there was a presence of a foreign body that was delivered by the stent, which persists about 2mm on the extremity of the balloon fragment which is above the proximal portion of the stent.It was also noted that there was no image of the mobile balloon in the coronary lumen.Post dilation was performed and the final result was satisfactory with timi 3 flow.The patient was monitored in the intensive care unit and it was noted that there was no arrhythmia or hemodynamic complications.

Manufacturer Narrative

Device is a combination product.(b)(4).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).

• Brand Name: PROMUS PREMIER?
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY; ballybrit business park; galway
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY; ballybrit business park; galway
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 4693162
• MDR Text Key: 5711412
• Report Number: 2134265-2015-02572
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P110010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2015
• 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
• Date Manufacturer Received: 03/19/2015
• 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
• Treatment: 20MM X 4.00MM NC QUANTUM APEX¿ BALLOON
• Patient Outcome(s): Hospitalization; Required Intervention