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

Catalog Number 1011708-38

Device Problem Break (1069)

Patient Problems Pain (1994); Numbness (2415)

Event Date 12/15/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).It is indicated that the device is not returning for evaluation; therefore, a failure analysis of the complaint device could not be completed.A review of the lot history record and complaint history of the reported lot could not be conducted because the lot number was not provided.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

It was reported that on (b)(6) 2014, the procedure was to treat a lesion in the right coronary artery (rca), a lesion in the diagonal ramus, and a lesion in the left marginal ramus.The 3.0x33mm xience prime and 2.75x38mm xience prime stent implants were deployed in the rca with no reported issue.The 3.5x18mm xience prime and 3.5x23mm xience prime stent implants were deployed in the diagonal ramus with no reported issue.The 3.5x15mm xience prime stent implant was deployed in the left marginal ramus with no reported issue.Angiogram was performed and stenosis was noted to be reduced to 0% for all lesions.The procedure was completed with no reported device or procedure issues.On an unspecified date, the patient began experiencing pain, discomfort, and numbness in the arm.On (b)(6) 2014, computed tomography angiography revealed a suspected stent fracture in the rca.On (b)(6) 2014, the stent fracture was confirmed, which was treated with deployment of an unspecified drug-eluting stent (des).There was no additional information provided.

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Date of event has been estimated.Concomitant medical products: stent: 3.0x33mm xience prime, 3.5x18mm xience prime, 3.5x23mm xience prime, 3.5x15mm xience prime the stent remains in the patient.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The 3.0x33mm xience prime referenced, is being filed under a separate medwatch mfr number.

• Brand Name: XIENCE PRIME LL 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 462
• Manufacturer (Section G): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; abbott vascular; 26531 ynez road; temecula CA 92591 462
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 4758493
• MDR Text Key: 16758237
• Report Number: 2024168-2015-02596
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 04/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1011708-38
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/16/2015
• Initial Date FDA Received: 05/08/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/17/2015
• 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 Outcome(s): Hospitalization; Required Intervention