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

Catalog Number 1500200-12

Device Problems Improper or Incorrect Procedure or Method (2017); Failure to Advance (2524); Device Dislodged or Dislocated (2923)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Angina (1710); Non specific EKG/ECG Changes (1817); Ischemia (1942); Foreign Body In Patient (2687)

Event Date 04/18/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.The additional 2.0x12mm xience sierra device referenced is being filed under a separate medwatch report.Description of problem or event: a non-abbott 2.0x15mm sds was advanced and the stent was also deployed.The patient experienced intermittent severe chest pain associated with st depression on ecg, which was associated with reduced blood flow through the lad.The stenosed part of the vessel continued to be ballooned with an unspecified bdc; however, the decision was made to perform an urgent coronary artery bypass graft.A balloon pump was then inserted, and the bmw guide wire remained in place to secure access across the lesion in the lad.The patient was transferred to the operating room and surgery was performed.No additional information was provided.

Event Description

It was reported that the procedure was performed to treat a lesion in the mid left anterior descending (lad) coronary artery.After implanting two 2.0x18mm xience sierra stents, a 2.0x12mm xience sierra stent delivery system (sds) was opened and was not prepped per the instructions for use (ifu).The sds was advanced but would not cross the lesion.The sds was removed, and the vessel was ballooned with an unspecified balloon dilatation catheter (bdc).It was then noted that the 2.0x12mm stent was missing on the sds balloon.The patient was x-rayed and the cath lab area was searched; however, the stent was not found, and the physician suggested that the ballooning had crushed the stent into the vessel wall.A second 2.0x12mm xience sierra sds was then opened and was not prepped per the ifu.The sds was advanced but would not cross the lesion.The sds was removed, and it was noted that the stent was not mounted on the balloon.An unspecified bdc was then advanced through the dislodged stent, and the stent was deployed.A non-abbott 2.0x15mm stent was also deployed.The patient experienced intermittent severe chest pain associated with st depression on ecg, which was associated with reduced blood flow through the lad.The stenosed part of the vessel continued to be ballooned; however, the decision was made to perform an urgent coronary artery bypass graft.A balloon pump was inserted, and the patient was transferred to the operating room and surgery was performed.No additional information was provided.

Manufacturer Narrative

Patient codes: 2687 not labeled.Device codes: 2017 labeled.Internal file number - (b)(4).Correction: mfr site registration #.Correction: patient code 1204 removed.Device code 2017 - distal to stent.Evaluation summary: the device was returned for analysis.The reported stent dislodgement was confirmed.The reported failure to advance the device was unable to be replicated in a testing environment as it was based on operational circumstances.It should be noted that the xience sierra everolimus eluting coronary stent system instruction for use (ifu) lists device preparation to be performed prior to delivery procedure.In addition, the ifu notes: when treating multiple lesions within the same vessel, stent the distal lesion prior to stenting the proximal lesion.In this case, the ifu deviation related to crossing a previously implanted stent may have contributed to the reported stent dislodgement.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 identified no other incidents from this lot.The investigation determined the reported difficulties and treatment appear to be related to circumstances of the procedure, as it is likely the device interacted with the difficult anatomy and/or previously implanted stents while attempting to cross distally, causing the reported failure to advance, subsequent stent dislodgement and patient effects.The reported patient effects of angina and ischemia are listed in the xience sierra everolimus eluting coronary stent systems ifu as known patient effects of coronary stenting procedures.There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.

Event Description

Subsequent to the initially filed report, the following information was received: the mid left anterior descending coronary artery was 70% stenosed, moderately tortuous and heavily calcified.The first 2.0x18mm xience sierra stent delivery system (sds) would not cross due to the anatomy.Both of the 2.0x12mm xience sierra stents were attempting to advance distal to the previously implanted 2.0x18mm xience sierra stents.It could not be confirmed if the 2.0x12mm xience sierra devices would not pass [cross] due to the anatomy or due to interaction with previously implanted 2.0x18mm xience sierra stents.Both dislodged 2.0x12mm xience sierra stents were deployed in the proximal part of the vessel, which was also calcified.A dissection was noted after the deployment of the non-abbott 2.0x15mm stent.Due to the dissection that occurred, and flow being lost, the lesion could not be treated with a stent and the patient was taken for coronary artery bypass graft surgery (cabg).No additional information was provided.

• 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
• MDR Report Key: 8609423
• MDR Text Key: 145024560
• Report Number: 2024168-2019-03794
• 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: 08/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Catalogue Number: 1500200-12
• Device Lot Number: 8101941
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2019
• Date Manufacturer Received: 07/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GUIDE WIRE: BMWSTENT: 2.0X18MM XIENCE SIERRA (2); GUIDE WIRE: BMWSTENT: 2.0X18MM XIENCE SIERRA (2)
• Patient Outcome(s): Required Intervention; Disability