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

Model Number 9552

Device Problem Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/16/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Device is a combination product.Device evaluated by mfr.: promus premier ous mr 28 x 3.00 mm stent delivery system was returned for analysis.A visual examination of the stent found that the stent was damaged on the fifth distal first stent strut row, with a stent strut lifted from crimped stent position.The undamaged crimped stent outer diameter was measured and the result is within the maximum crimped stent profile measurement.Stent damage most likely occurred when a stent strut was caught in calcification.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 examination of the tip showed signs of damage on the distal edges of the tip.Tip damage most likely occurred when the tip was pushed against a restriction.A visual and tactile examination found no issues with the hypotube shaft.A visual and tactile examination of the outer lumen and mid-shaft section and a visual examination of the inner lumen found no issues with the extrusion shaft.No other issues were identified during the product analysis.

Event Description

Reportable based on device analysis completed on 18may2020.It was reported that advancing difficulty was encountered.The 90% stenosed target lesion was located in the proximal end of the left anterior descending (lad) artery with unstable plaques, and there was a 70% stenosis in the distal end of the lad artery.After the lesion was pre-dilated, a 2.75 x 28 stent was successfully deployed.Then a 28 x 3.00 promus premier drug-eluting stent was advanced, but resistance was encountered.The device was removed and the procedure was completed with another of the same device.There were no patient complications reported and the patient's status was stable.However, returned device analysis revealed a stent damage.

• 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 CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 10135706
• MDR Text Key: 194557846
• Report Number: 2134265-2020-06957
• 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: 06/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/11/2021
• Device Model Number: 9552
• Device Catalogue Number: 9552
• Device Lot Number: 0024472041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/18/2020
• Initial Date FDA Received: 06/09/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/12/2019
• 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: 54 YR
• Patient Weight: 46