MAUDE Adverse Event Report: AV-TEMECULA-CT ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM; BIORESORBABLE DRUG ELUTING SCAFFOLD

Catalog Number 1012464-18

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Hemorrhage/Bleeding (1888); Perforation (2001); Renal Failure (2041); Respiratory Distress (2045); Swelling (2091)

Event Date 11/23/2017

Event Type  Death  

Manufacturer Narrative

The patient and device codes were coded by the manufacturer.(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The scaffold remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all relevant information.The other absorb device referenced is being filed under a separate medwatch report.The absorb device is currently not commercially available in the u.S; however, it is similar to a device sold in the u.S.

Event Description

It was reported that the patient presented with long term heart discomfort.The procedure in (b)(6) 2016 was to treat a lesion located in the left anterior descending (lad) artery.An unspecified absorb scaffold was implanted.After the procedure the patient recovered well with no adverse effects.On (b)(6) 2017 the patient reported heart discomfort and underwent a thallium (nuclear) scan.An inferior myocardial infarction was discovered.The patient was admitted for a percutaneous coronary intervention and a 3.5x18mm absorb scaffold was implanted for treatment.Post-dilatation was performed and a perforation occurred.The patient was transferred to another hospital and underwent a small operation to repair the perforation.There was no more bleeding but heart function was already severely damaged.The patient was placed on extracorporeal membrane oxygenation (ecmo) to survive.The next morning the patient's vital signs were critical due to severe hemopneumothorax of the right lung and intubation was performed.The patient's face was very swollen reportedly due to the perforation.The patient died on january 8, 2018 reportedly due to acute renal failure and multiple organ failure.No additional information was provided.

Manufacturer Narrative

(b)(4).There was no reported device malfunction and the product was not returned as the scaffold remains in the anatomy.A review of the lot history record of the reported device could not be conducted because the lot number was not provided.The reported patient effects of death, perforation and renal failure as listed in the bioresorbable vascular scaffold (bvs) system, absorb, instructions for use are known adverse events associated with the use of a coronary scaffold in native coronary arteries.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.

• Brand Name: ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM
• Type of Device: BIORESORBABLE DRUG ELUTING SCAFFOLD
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; 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: 7334937
• MDR Text Key: 102247742
• Report Number: 2024168-2018-01766
• Device Sequence Number: 1
• Product Code: PNY
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: P150023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 1012464-18
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: SCAFFOLD: UNK ABSORB; SCAFFOLD: UNK ABSORB; SCAFFOLD: UNK ABSORB
• Patient Outcome(s): Death
• Patient Age: 66 YR