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

Catalog Number	1550250-33
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Angina (1710); Thrombosis (2100)
Date of Event	04/02/2019
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.(b)(4).The device was not returned for evaluation.A review of the lot history record and complaint history could not be conducted because the lot number was not provided.It should be noted that the xience sierra, everolimus eluting coronary stent system, instructions for use, specifies the rated burst pressure (rbp) is 16 atmospheres and clearly states not to exceed the rbp.Use of pressures higher than specified on the product label may result in a ruptured balloon with possible intimal damage and dissection.The investigation was unable to determine a conclusive cause for the reported difficulty to deploy (wall apposition); however, the subsequent treatments appear to be related to the circumstances of the procedure.The reported patient effects of angina and thrombosis are listed in the xience sierra ifu as known patient effects of coronary stenting procedures.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.
Event or Problem Description
It was reported that on (b)(6) 2019, the patient had the 2.50.33 mm xience sierra stent implanted at 20 atmospheres (atm) in the heavily calcified, moderately tortuous proximal left anterior descending coronary artery.The patient was still in the hospital due to other health issues on (b)(6) 2019 when it was noted there was an acute closure of the xience sierra stent in the lad.The patient was experiencing chest pain, so the films from (b)(6) 2019 were reviewed and it was noted the sierra stent was dogboned and severely under-deployed in multiple areas.Thrombus was noted throughout the entire stent.Thrombectomy was performed followed by multiple balloon inflations with a high pressure balloon to successfully appose the stent.The patient is stable and doing fine.No additional information was provided.

• Brand Name: XIENCE SIERRA 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: 8515649
• Report Number: 2024168-2019-02935
• Device Sequence Number: 19505573
• Product Code: NIQ
• UDI-Device Identifier: 08717648227134
• UDI-Public: 08717648227134
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/15/2019

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 1550250-33
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2019
• Initial Report FDA Received Date: 04/15/2019
• 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: 72 YR