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 07/21/2020

Event Type  malfunction  

Manufacturer Narrative

Initial reporter facility name - (b)(6).Device evaluated by mfr.: promus premier ous mr 28 x 4.00 stent delivery system was returned for analysis.A visual examination of the stent found stent damage.Mid- struts were noted to be lifted.The undamaged stent outer diameter was measured and the result was within maximum crimped stent profile.The balloon was 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 kinks.A visual and tactile examination of the shaft polymer extrusion found no issues.An examination (visual and via scope) found damage.Device tracked without issues on a 0.0140 inch test guidewire.No other issues were identified during the product analysis.

Event Description

Reportable based on device analysis completed on 15sep2020.It was reported that advancing difficulties were encountered.The 90% stenosed target lesion with unstable plaques was located in the severely tortuous proximal end of the left anterior descending artery (lad) and 80% stenosis in the mid lad.After predilatation was performed with a 2.5 x 15 balloon catheter, a 3.5 x 28 stent was placed.Subsequently, a 28 x 4.00 promus premier drug-eluting stent was advanced in the proximal lad.However, the device met great resistance due to severe tortuousity.Physician attempted several times but eventually retrieved the device.The procedure was completed with another of the same device.There were no patient complications reported and the patient status was stable.However, returned device analysis revealed 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: 10626861
• MDR Text Key: 209793673
• Report Number: 2134265-2020-13012
• 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: 10/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/24/2020
• Device Model Number: 9552
• Device Catalogue Number: 9552
• Device Lot Number: 0022458974
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/15/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/25/2018
• 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: 69 YR
• Patient Weight: 51