MAUDE Adverse Event Report: AV-TEMECULA-CT XIENCE XPEDITION 48 EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT SYSTEM

Catalog Number 1070300-48

Device Problems Deflation Problem (1149); Entrapment of Device (1212)

Patient Problems No Consequences Or Impact To Patient (2199); Cardiogenic Shock (2262)

Event Date 01/27/2019

Event Type  Death  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.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.

Event Description

It was reported that the procedure was to treat the left anterior descending artery that did not have any tortuosity or calcification.On (b)(6) 2019, pre-dilatation was performed with an unspecified balloon catheter.A 3.0 x 48 mm xience xpedition stent was implanted and medication was administered to the patient (ticagrelor, aspirin and novostatin).The stent delivery balloon was inflated once at 14 atmospheres during implantation.Angiography revealed that the stent was well apposed to the lesion.However, the stent delivery balloon completely failed to deflate and the device could not be removed from the anatomy.Therefore, the patient was sent to surgery and expired on (b)(6) 2019.According to the opinion of the physician, the stent delivery system caused the death.No additional information was provided.

Manufacturer Narrative

Internal file number - (b)(4).Correction: date of event corrected to (b)(6) 2019.Case description (procedure date corrected to (b)(6) 2019).Date of relevant tests corrected to (b)(6) 2019.Implant date corrected to (b)(6) 2019.

Event Description

Correction to the case details: the procedure was performed on (b)(6) 2019 and not (b)(6) 2019.No additional information was provided.

Manufacturer Narrative

(b)(4).Correction: date of occurrence.(b)(4).Evaluation summary: a visual inspection was performed on the returned device.The reported entrapment of the device could not be tested as it was based on operational circumstances.The reported deflation issue could not be tested due to the condition of the returned device.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 similar incidents from this lot.The reported patient effect of death is listed in the xience xpedition, everolimus eluting coronary stent system (eecss), instructions for use as a known patient effect of coronary stenting procedures.The investigation was unable to determine a conclusive cause for the reported deflation issue and entrapment of the device.There was no damage noted to the device prior to use during preparation which suggests a quality issue did not contribute to the reported difficulties.Further manipulation of the device, as the balloon became entrapped on the stent implant during retraction, ultimately contributed to the noted shaft separation; however, a definitive cause cannot be determined.In addition, the reported patient effect of death is considered a potential adverse event of coronary stenting procedures.Based on the information reviewed and analysis of the returned device, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.A cine was received and reviewed by an abbott vascular clinical specialist.The reviewer noted after pre-dilatation at two locations a long stent was positioned and expanded in the left anterior descending (lad).The balloon of the stent delivery system (sds) could not be deflated.For 30 minutes the operator tried to deflate/ rupture the balloon without success.In the last series of images an intra-aortic balloon pump (iabp) was positioned and activated.It was reported that the patient was transported to surgery and later the patient expired.Patient required emergent coronary artery surgery to remove the sds from the lad.Death in this case may be due to the inability to deflate the sds balloon.

Event Description

Subsequent to the initial report, additional information was provided.The stent delivery balloon was later removed from the anatomy during surgery.Additionally, review of the cine revealed that an intra-aortic balloon pump (iabp) was inserted during the event.No additional information was provided.

Manufacturer Narrative

Internal file number - (b)(4).Correction: the investigation was unable to determine a conclusive cause for the reported deflation issue and entrapment of the device.In this case, it is possible the noted inner/outer member became stretched during the procedure, thus causing the reported balloon deflation issue.Further manipulation of the device, as the balloon became entrapped on the stent implant during retraction, ultimately contributed to the noted shaft separation; however, a definitive cause cannot be determined.Based on the case information, the reported deflation issue is a potential product quality issue.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.

Manufacturer Narrative

Internal file number - (b)(4).Correction: pma/510k: the alert date was filed incorrectly on medwatch follow-up #4 as 07/23/2016, but should have been 07/23/2019.The xience xpedition 48 is currently not commercially available in the u.S.; however, it is similar to a device sold in the u.S.

• Brand Name: XIENCE XPEDITION 48 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: 8395272
• MDR Text Key: 137980346
• Report Number: 2024168-2019-01731
• 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,distri
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/12/2021
• Device Catalogue Number: 1070300-48
• Device Lot Number: 8110741
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/06/2019
• Date Manufacturer Received: 08/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death