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

Model Number H7493952832400

Device Problems Bent (1059); Migration or Expulsion of Device (1395); Difficult to Remove (1528); Device Damaged by Another Device (2915)

Patient Problem Hematoma (1884)

Event Date 10/23/2015

Event Type  Injury  

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).

Event Description

It was reported that stent damage occurred and hematoma occurred.The target lesion was a restenosis of a full metal jacket in the right coronary artery (rca).A 4.00x32mm promus premier drug eluting stent was advanced to treat the lesion.However, the stent was caught in the proximal end of the restenosed stent and became accordioned.During removal, the stent was caught in the rca and drifted down.A vascular surgeon was eventually able to pull out the 4.00x32mm promus premier drug eluting stent.Following removal of the device, the patient had a large hematoma.No surgery took place to treat the hematoma.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: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5260138
• MDR Text Key: 32459941
• Report Number: 2134265-2015-08029
• 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
• Report Date: 11/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: H7493952832400
• Device Catalogue Number: 39528-3240
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2015
• 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
• Patient Outcome(s): Other