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

Catalog Number 1550275-28

Device Problems Difficult to Remove (1528); Failure to Advance (2524); Device Dislodged or Dislocated (2923)

Patient Problems Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Respiratory Distress (2045)

Event Date 02/09/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Weight: actual weight (b)(6).Event description continued: it was reported that the patient arrived emergently with complaints of angina and was evaluated for st-elevation myocardial infarction.The patient had reportedly stopped their meds; however, no reason was provided.The procedure was to treat a lesion with no calcification or tortuosity in the ramus coronary artery.A 3.5 x 28 mm xience sierra stent delivery system (sds) was deployed in the proximal left anterior descending (lad).A 2.75 x 28 mm xience sierra sds was advanced to treat the ramus, but met resistance potentially with the proximal end struts of the stent implant that were protruding into the left main artery.When pulling back the sds to reposition, the stent became caught with the implanted stent.The stent dislodged in the left main and was free floating.At this point, the patients pressure dropped which required cardiopulmonary resuscitation (cpr), intubation and extracorporeal membrane oxygenation (ecmo).Therefore, the patient was sent for surgery to retrieve the dislodged stent.No additional information was provided.The device was not returned.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The additional xience sierra device referenced is being filed under a separate medwatch report.(b)(4).

Event Description

User facility medwatch report received states: describe the event or problem: undeployed stent.Patient requiring percutaneous coronary intervention (pci).Brought into the cardiac catheterization laboratory(cath lab) for further evaluation of the st-elevation myocardial infarction.Patient was previously treated at another facility but details are unknown.Per patient, stopped all cardiac meds.No reason given and medication names not provided.Patient arrived via paramedics as a stemi alert with chest pain.Once in the cath lab he was under moderate sedation.Percutaneous transluminal coronary angioplasty and stenting of the proximal left anterior descending coronary artery with a 3.5 x 28 mm xience sierra drug-eluting stent.Percutaneous transluminal coronary balloon angioplasty of the ramus intermedius coronary artery with unsuccessful attempt at stent deployment.Insertion of venous and arterial catheters for extracorporeal membrane oxygenation.Cardiopulmonary resuscitation on ecmo.Red lined to or for cabg x3 and stent removal.Now in cticu on ventilator/ecmo.

Manufacturer Narrative

(b)(4).Correction: return status - device status changed from returning to not returned.The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history did not indicate a lot specific quality issue.The reported patient effects of hypotension and cardiac arrest are listed in the xience sierra everolimus eluting coronary stent systems instructions for use as known patient effect(s) of coronary stenting procedures.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely the device interacted with the previously deployed stent causing the reported failure to advance.The device was then removed and interacted with the previously deployed stent causing the reported difficulty to remove and stent dislodgement with the patient effects of cardiac arrest, hypotension, respiratory distress, surgical procedure, removal of a foreign body, and additional therapy/non-surgical treatment.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: XIENCE SIERRA 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): CLONMEL, IRELAND REG# 9616693; 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: 8400944
• MDR Text Key: 138142110
• Report Number: 2024168-2019-01784
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/10/2019
• Device Catalogue Number: 1550275-28
• Device Lot Number: 8083041
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2018
• 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
• Treatment: STENT: 3.5 X 28 MM XIENCE SIERRA
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Weight: 87