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

Catalog Number	1011734-38
Health Effect - Clinical Code	Angina (1710)
Date of Event	03/28/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was not returned for evaluation.The reported patient effect of angina is listed in the xience prime long length (ll) everolimus eluting coronary stent systems instructions for use as a known patient effect of coronary stenting procedures.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.A conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that the procedure was to treat a lesion in the anterior descending artery.On (b)(6) 2013, the patient presented with unstable angina.Three xience prime stents (3.5 x 38 mm, 3.5 x 18 mm, and 2.5 x 28 mm) were implanted without issues.The patient was discharged and given medication.On (b)(6) 2014, the patient was re-hospitalized with chest pain worse than four years and three months ago.Medications were administered and the patient was discharged on (b)(6) 2014.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).Correction: the 'date received by mfr' date was filed incorrectly on the initial medwatch report as 12/18/2017, but should have been 11/12/2017.

• Brand Name: XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Common Device Name: DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 7191627
• Report Number: 2024168-2018-00385
• Device Sequence Number: 1497522
• Product Code: NIQ
• UDI-Device Identifier: 08717648177279
• UDI-Public: 08717648177279
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2018

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
• Operator of Device: Health Professional
• Device Catalogue Number: 1011734-38
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/18/2017
• Supplement Date Received by Manufacturer: 02/15/2018
• Initial Report FDA Received Date: 01/15/2018
• Supplement Report FDA Received Date: 02/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 39 YR