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

Model Number 9554

Device Problems Material Puncture/Hole (1504); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/29/2019

Event Type  malfunction  

Manufacturer Narrative

Device is a combination product.Device evaluated by mfr.: promus premier ous mr 38 x 2.50mm stent delivery system was returned for analysis.The device was returned with stent protector and pig-tail mandrel attached.Both were removed distally without issue.A visual examination of the stent found no issues.There was no sign of damage, stretching or lifting of the stent struts.The stent showed no signs of movement and was set between the proximal and distal markerbands.The crimped stent od (outer diameter) was measured and the result was within maximum crimped stent profile measurement.The balloon cones were reviewed and no issues were noted.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.A visual and tactile examination of the hypotube found multiple hypotube kinks at several locations along the hypotube shaft.A visual examination of the outer and inner lumen and mid-shaft section found outer shaft polymer extrusion tears at two locations; 1cm and 2cm distal to the port bond site, with evidence of stretching/twisting of the outer shaft polymer extrusion at the same locations.A visual and microscopic examination of the bumper tip found distal tip damage.No other issues were identified during the product analysis.

Event Description

Reportable based on additional information received on 04sep2019.It was reported the shaft tore.The 60% stenosed, 38mm in length target lesion was in the mildly tortuous, moderately calcified, 2.5mm in diameter right coronary artery.A 38 x 2.50 promus premier drug-eluting stent was advanced for treatment.However, during the procedure the delivery shaft kinked, and cause the shaft to tear.The procedure was completed with another of the same device.There were no patient complications nor injuries reported and the patient was stable.

• Brand Name: PROMUS PREMIER
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC IRELAND LIMITED; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 9124596
• MDR Text Key: 160205526
• Report Number: 2134265-2019-11505
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 09/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/18/2021
• Device Model Number: 9554
• Device Catalogue Number: 9554
• Device Lot Number: 0023406605
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/04/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/19/2019
• 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 Age: 73 YR
• Patient Weight: 74