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

Model Number H7493925112400

Device Problems Bent (1059); Peeled/Delaminated (1454); Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/10/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Event Description

It was reported that the stent damage and stent dislodgment occurred.The target lesion was located in a coronary artery.A 12mm x 4.00mm promus premier¿ drug eluting stent was advanced to treat a vessel.However, it was noted that the stent strut was lifted and the stent dislodged.No patient complications were reported.

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that no stent dislodgement occurred.The black coating was detached off the delivery shaft and the silver metal was exposed on the shaft.

Manufacturer Narrative

Promus premier ous mr 12 x 4.00mm stent delivery system (sds) was returned for analysis.The stent appeared to have been expanded and was damaged.The balloon folds were open.It appeared that the balloon may have been subjected to positive pressure.There appeared to be contrast media in the balloon.A visual and tactile examination found no issues with the hypotube.The hypotube was examined under a microscope and no issues with or damage to the coating was noted.A visual and tactile examination of the shaft polymer extrusion profile found no issues.A visual and microscopic examination found slight damage to the tip.No other issues were identified during the product analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause was unable to be determined.(b)(4).

Event Description

It was further reported that no stent dislodgement occurred.The black coating was detached off the delivery shaft and the silver metal was exposed on the shaft.

Manufacturer Narrative

Describe event or problem updated.(b)(4).

Event Description

It was further reported that the detachment of the shaft coating was noted before the device entered inside the patient and there was no attempt to deploy the stent.

• 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: 6583999
• MDR Text Key: 75729065
• Report Number: 2134265-2017-05465
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: CN
• 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,Followup,Followup,Followup
• Report Date: 05/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/11/2018
• Device Model Number: H7493925112400
• Device Catalogue Number: 39251-1240
• Device Lot Number: 19598962
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/29/2016
• 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
• Patient Age: 65 YR