MAUDE Adverse Event Report: AV-TEMECULA-CT XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT SYSTEM

Catalog Number UNK XIENCE

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/25/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The stent remains in the patient.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The nc trek referenced is filed under a separate medwatch report number.

Event Description

It was reported that the procedure was to treat a moderately calcified ostial right coronary artery.A 4.0x8mm xience stent was implanted, but after post-dilatation with a 4.5 nc balloon, there was suboptimal expansion at the ostium.Additional post-dilatation was done with a 5.0x8mm nc trek balloon dilatation catheter (bdc) with one inflation at 18 atmospheres.During removal of the bdc, resistance was noted as the device would not retract into the guide catheter (gc).The balloon detached from the delivery catheter.It was thought that the balloon did not fully deflate.Another attempt was made to remove the bdc, but resistance remained.The bdc was pulled into the gc and the shaft separated inside the gc.The guide wire, bdc, and the guide catheter were removed as a single unit out of the patient, successfully.Once out of the anatomy, the bdc shaft was noted stuck inside the 6 (b)(6) sheath with portions of the shaft coming out.The bdc shaft was pulled out of the sheath post-procedure.In the physicians opinion, the balloon did not deflate entirely prior to the attempt to remove it from the anatomy, causing it to pull out of the gc.The procedure was completed successfully.There was no reported adverse patient effect or a clinically significant delay in the procedure.

Manufacturer Narrative

(b)(4).Unique device identifier (udi): the udi is unknown because the part number and lot number were not provided.The device was not returned for analysis.A review of the lot history record and complaint history of the reported lot could not be conducted because the part and lot number were not provided.The investigation determined a conclusive cause for the reported difficulties cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Type of Device: DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 7802021
• MDR Text Key: 117834833
• Report Number: 2024168-2018-06426
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P070015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 09/25/2018

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 Catalogue Number: UNK XIENCE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/31/2018
• Initial Date FDA Received: 08/21/2018
• Supplement Dates Manufacturer Received: 09/24/2018
• Supplement Dates FDA Received: 09/25/2018
• 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 Age: 80 YR