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

Device Problems Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/10/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Date of event: date of event has been estimated.Implant date: date of implant has been estimated.(b)(4).The stent remains in the patient.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that an unknown rx xience prime stent was implanted in the dorsalis pedis (foot).Use of the xience prime stent in the dorsalis pedis is considered off-label use and as a result the patient had to have their foot amputated.No additional information was provided.

Manufacturer Narrative

Internal file number - (b)(4).The udi is unknown because the part and lot numbers 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 numbers were not provided.It was reported xience prime was implanted in the dorsalis pedis (foot).It should be noted that the xience prime everolimus eluting coronary stent system instruction for use states: the xience prime, xience prime sv, and xience prime ll everolimus eluting coronary stent systems are indicated for improving coronary luminal diameter in patients with symptomatic ischemic heart disease due to discrete de novo native coronary artery lesions.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: XIENCE PRIME 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
• MDR Report Key: 8400241
• MDR Text Key: 138123508
• Report Number: 2024168-2019-01776
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/25/2019

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/11/2019
• Initial Date FDA Received: 03/07/2019
• Supplement Dates Manufacturer Received: 03/14/2019
• Supplement Dates FDA Received: 03/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention